This follow-up is being submitted to relay additional information.Visual examination of the provided pictures identified product that had been implanted.The articular surface looks worn, and the tibial plate and femoral implant have biological material on them.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: fit and alignment appropriate, no evidence of metallosis, wear on bearing.Device history record (dhr) was reviewed for deviations and/ or anomalies with no deviations / anomalies identified.A definitive root cause cannot be determined.This complaint for implant wear is confirmed via provided photos, however metallosis could not be confirmed.If any further information is received 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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