Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 33175 - metallic femoral head prosthesis - the ultamet metal femoral head is made from cobalt chrome and press-fits onto a 9/10 tapered femoral stem. it articulates with a polyethylene liner only or natural acetabulum. the ultamet metal femoral head is one component of a total or hemi hip arthroplasty. total hip arthroplasty is is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. hemi-hip arthroplasty is where there is evidence of a satisfactory natural acetabulum and sufficient femoral bone to seat and support the femoral stem and head. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis. additionally, hemi-hip arthroplasty is indicated in the following conditions: 1. acute fracture of the femoral head or neck that cannot be appropriately reduced and treated with internal fixation. 2. fracture dislocation of the hip that cannot be appropriately reduced and treated with internal fixation. 3. non-union of femoral neck fractures. 4. certain high subcapital and femoral neck fractures in the elderly. 5. degenerative arthritis involving only the femoral head in which the acetabulum does not require replacement. 6. pathology involving only the femoral head/neck and/or proximal femur that can be adequately treated by hemi-hip arthroplasty.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 34203 - uncoated femoral stem prosthesis, modular - a cemented cobalt chrome femoral stem with a 12/14 taper, circulotrapezoidal neck, and longitudinal stem taper. the femoral canal is rasped with sequential broaches. after trialing and femoral canal preparation, a buck cement restrictor is inserted into the canal and cement is injected from a pressurized gun. a stem driver is used to drive the stem into the femoral canal. excess cement should be removed prior to femoral head impaction on the neck taper. a sterile femoral component of a total hip system. the stem was designed for revision of femoral distal defects such as holes, windows, or fractures around the end of the previously implanted stem. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 33175 - metallic femoral head prosthesis - a sterile implantable stainless steel femoral head offered in various sizes with built-in neck offset adjustments to better match patient needs. it is designed to mate with a stainless steel femoral stem through a corresponding 12/14 taper. the device is designed to articulate with a polyethylene liner and is impacted onto the femoral stem with a mallet. a stainless steel femoral head component of a total hip system, for use only with a stainless steel femoral stem with a corresponding 12/14 taper. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 33175 - metallic femoral head prosthesis - a sterile implantable artificial femoral head that is made of a cobalt chrome alloy and is designed to mate with a titanium taper sleeve and articulate with a polyethylene acetabular prosthesis as part of a total hip arthroplasty. modular heads are designed to fit on any smith & nephew femoral stem. the taper sleeve is firmly placed on the taper and the modular head is placed on the sleeve and impacted with a mallet. a sterile femoral head component of a total hip system. it attaches to a sleeve placed on the trunnion of a femoral stem prosthesis and articulates with an acetabulum prosthesis. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 38156 - ceramic femoral head prosthesis - a sterile implantable artificial femoral head that has an oxidized zirconium ceramic surface and is designed to mate with a titanium taper sleeve and articulate with a polyethylene acetabular prosthesis as part of a total hip arthroplasty. modular heads are designed to fit on any smith & nephew femoral stem. the taper sleeve is firmly placed on the taper and the modular head is placed on the sleeve and impacted with a mallet. a sterile femoral head component of a total hip system. it attaches to a sleeve placed on the trunnion of a femoral stem prosthesis and articulates with an acetabulum prosthesis. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 38156 - ceramic femoral head prosthesis - a sterile implantable artificial femoral head that has an oxidized zirconium ceramic surface and is designed to mate with a hip stem through a corresponding 12/14 taper and to articulate with a polyethylene acetabular prosthesis as part of a total hip arthroplasty. following a trial reduction with a femoral head trial, the neck taper of the stem is wiped clean with a sterile cloth and the femoral head is placed onto the neck taper and firmly impacted with a mallet. a sterile femoral head component of a total hip system. it attaches to the trunnion of a femoral stem prosthesis and articulates with an acetabulum prosthesis. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 33175 - metallic femoral head prosthesis - a sterile implantable artificial femoral head that is made of a cobalt chrome alloy. it is designed to mate with a hip stem through a corresponding 12/14 taper and to articulate with a polyethylene acetabular prosthesis as part of a total hip arthroplasty. following a trial reduction with a femoral head trial, the neck taper of the stem is wiped clean with a sterile cloth and the femoral head is placed onto the neck taper and firmly impacted with a mallet. a sterile femoral head component of a total hip system. it attaches to the trunnion of a femoral stem prosthesis and articulates with an acetabulum prosthesis. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

smith & nephew pty ltd - 38156 - ceramic femoral head prosthesis - a sterile implantable artificial femoral head that is made of an alumina zirconia material composite designed to mate with a hip stem through a corresponding 12/14 taper and to articulate with an acetabular prosthesis as part of total hip arthroplasty. following a trial reduction with a femoral head trial, the neck taper of the stem is wiped clean with a sterile cloth and the femoral head is placed onto the neck taper and firmly impacted with a mallet. a sterile implantable spherical component of a total hip system intended to replace the anatomical femoral head. it attaches to the trunnion of a femoral stem prosthesis and articulates with an acetabulum prosthesis. hip components are indicated for individuals undergoing primary and revision surgery where other treatments or devices have failed in rehabilitating hips damaged as a result of trauma or noninflammatory degenerative joint disease (nidjd) or any of its composite diagnoses of osteoarthritis, avascular necrosis, traumatic arthritis, slipped capital epiphysis, fused hip, fracture of the pelvis, and diastrophic variant. hip components are also indicated for inflammatory degenerative joint disease including rheumatoid arthritis, arthritis secondary to a variety of diseases and anomalies, and congenital dysplasia; treatments of nonunion, femoral neck fracture, and trochanteric fractures of the proximal femur with head involvement that are unmanageable using other techniques; endoprosthesis, femoral osteotomy, or girdlestone resection; fracture-dislocation of the hip; and correction of deformity.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 38156 - ceramic femoral head prosthesis - a biolox delta ts ceramic femoral head is composed of a packaged biolox delta ceramic femoral head with metal tapered sleeve adapters. the biolox delta ts ceramic femoral head is manufactured from biolox delta alumina matrix composite ceramic. the biolox delta ts ceramic head is intended to allow assembly with depuy femoral hip stem tapers, either in a primary hip replacement surgery, or in revision hip replacement surgery with well-fixed femoral stems. the depuy delta taper sleeve (ts) ceramic femoral head is intended for use in total hip arthroplasty applications to replace the articular surface of the femoral head in primary hip surgery and for the salvage of a failed previous hip surgery. total hip arthroplasty is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, hemiarthroplasty, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.

Úc - Tiếng Anh - Department of Health (Therapeutic Goods Administration)

johnson & johnson medical pty ltd t/a depuy synthes - 34191 - coated femoral stem prosthesis, modular - the corail amt ha size 6 collarless femoral stem is made from titanium and coated in hydroxyapatite for cementless fixation into the femoral canal and allows attachment of an appropriate taper femoral head. the full length of the stem has hydroxyapatite coating on the grit blasted surface which induces rapid osteointegration. corail amt ha coated size 6 femoral stems are intended for use in total hip arthroplasty which is intended to provide increased patient mobility and reduce pain by replacing the damaged hip joint articulation in patients where there is evidence of sufficient sound bone to seat and support the components. total hip replacement is indicated in the following conditions: 1. a severely painful and/or disabled joint from osteoarthritis, traumatic arthritis, rheumatoid arthritis, or congenital hip dysplasia. 2. avascular necrosis of the femoral head. 3. acute traumatic fracture of the femoral head or neck. 4. failed previous hip surgery including joint reconstruction, internal fixation, arthrodesis, surface replacement arthroplasty, or total hip replacement. 5. certain cases of ankylosis.