(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device was requested but not returned by the patient.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.(b)(4).Concomitant medical products: part#: unk, stryker speedset cement, lot#: unk.
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Reported event was confirmed by review of radiographs.Left total hip arthroplasty demonstrates a fracture in the femoral lining located in the subtrochanteric diaphysis.Periprosthetic lucencies noted surrounding the hardware within the proximal portion, including the trochanteric portion as well as the subtrochanteric portion up to the site of the fracture.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to be determined.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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