When a Major Orthopaedic Device Manufacturer Does Not Offer Replacement Components for Revision Surgeries

Put yourself in the place of your patient: undertaking hip or knee arthroplasty for diminution of pain and return of mobility, only to find out a decade later that your implant is corroding and the appropriate replacement part is not commercially available in the United States. For a percentage of patients, this isn’t hypothetical—it’s reality. When artificial joints fail, early or late, surgeons and their patients are sometimes left with no guarantee of appropriate, compatible components. In such cases, the options are less suitable or riskier implant parts, higher surgical complexity involving the removal of otherwise well-positioned and ingrown components, or a lengthy and expensive compassionate use approval process for custom implants (via the Expanded Access pathway).