(b)(4).Concomitant medical products: item #51-107110, taperloc complete micro femoral stem, lot #6283007; item #010000847, g7 acetabular liner, lot #628387; item #650-1056, biolox delta ceramic head, lot #2898741; item #650-1066, taper adapter, lot #2922739.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2019-03590.
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It was reported that bilateral patient underwent right total hip arthroplasty.Subsequently, approximately two and a half months post op the patient began experiencing pain.The patient is scheduled to have a revision surgery due to pain and implant loosening.However, no revision procedure has been reported to date.Additional information was requested, however none was available.
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