DePuy ASR - Prescribing Information

DePuy Total Hip System – DePuy ASR™ Modular Acetabular Cup System

Important

This Essential Product Information sheet does not include all of the information necessary for selection and use of a device. Please see full labeling for all necessary information.

Indications

The device is indicated for use in total hip replacement procedures for patients suffering severe pain and disability due to structural damage in the hip joint from rheumatoid arthritis, osteoarthritis, post-traumatic arthritis, collagen disorders, avascular necrosis, and nonunion of femoral fractures. Use of the prosthesis is also indicated for patients with congenital hip dysplasia, protrusio acetabuli, slipped capital femoral epiphysis and disability due to previous fusion, where bone stock is inadequate for other reconstruction techniques.

Contraindications

Use is contraindicated in cases with active or recent joint sepsis, insufficient bone stock, marked atrophy or deformity in the upper femur, skeletal immaturity, or where loss of musculature or neuromuscular disease would render the procedure unjustifiable.

Warnings

Improper prosthesis selection or alignment, inadequate fixation, use where contraindicated or in patients whose medical, physical, mental or occupational conditions will likely result in extreme stresses to the implant may result in premature failure due to loosening, fracture or wear. Early motion and load bearing should be carefully monitored. Use of other components other than those recommended could lead to loosening, wear, fracture during assembly and premature failure.

Adverse Events

Peripheral neuropathy, deep wound infection, and heterotopic bone formation have been reported following hip replacements. Subclinical nerve damage has also been reported more frequently, often associated with surgical trauma. Dislocation and subluxation resulting from improper positioning and/or muscle and fibrous tissue laxity may also occur, as may loosening and subsequent failure of the total hip prosthesis. Histological reactions have been reported as an apparent response to exposure to a foreign material. The actual clinical significance of these reactions is unknown. Implanted metal alloys release metallic ions into the body. In situations where bone cement is not used, higher ion release due to increased surface area of a porous coated prosthesis is possible. There have been reports of failure of bone to grow into porous surfaces and fix components. Shedding or fragmentation of the porous surface has been reported, with potential for release of metallic debris into the joint space. Radiolucencies of bone adjacent to porous surfaces have been noted, although the clinical significance of this observation is uncertain in many cases. Serious adverse effects may necessitate surgical intervention.

December 2006