(b)(4).(b)(6).Concomitant medical products: unknown partial persona femur, cat#:unk, lot#:unk; unknown partial persona articular surface, cat#:unk, lot#:unk.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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.Product location unknown.
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Reported event was confirmed from x-rays received.Device history record was reviewed and no discrepancies were found.Review of x-ray review report states that there is a periprosthetic fracture of the right tibia in the setting of a medial unicompartmental arthroplasty noted from x-rays before revision surgery with mal-alignment is present as a result of the tibial fracture.Since the patient was revised due to bone fracture that was caused due to bicycle fall, the root cause can be attributed to patient condition.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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