(b)(4).This follow-up report is being submitted to relay additional information.Proposed component code: mechanical (g04)- stem.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Dhr was reviewed and no discrepancies related to the reported event were found.The reported products were reviewed for compatibility and it was determined that the following implants are not compatible: the liner, head, and stem combination radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: left tha with fractured proximal femoral component.Possible cement fracture along the greater trochanter.The complaint cannot be confirmed.The root cause of the reported issue is attributed to user error, as the surgeon is only meant to implant the spacer mold for up to 180 days, as it is not designed to go beyond 180 days, as per ifu 01-50-1204.Given the provided medical records, the patient never received the second stage of the revision until 4 years later.If any further information is found which would change or alter any conclusions or information, a supplemental will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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