(b)(4).Concomitant medical products: 00875200932 crosslinked liner 63986950, 00801803202 verys femoral head 64044387, 00771100710 m/l taper stem 63968266, 00875705002 multi hole shell 64033374.(b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation, product has been discarded.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: 0001822565-2018-05456; 0001822565-2018-5457; 0001822565-2018-5459; 0002648920-2018-00720.
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It was reported a patient underwent a right total hip arthroplasty, subsequently the patient underwent debridement, all implants were removed and cement spacer mold was implanted less than one month post operatively due to infection.Attempts have been made and no further information has been provided.
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