(b)(4).Multiple mdrs were submitted for this event.Please see associated report(s): 0002648920-2017-00446, 0001822565-2017-04799, 0002648920-2017-00454, 0001822565-2017-04947.Concomitant medical products: versys femoral head/ pn 00801803602/ ln 63177082, versys femoral stem/ pn 00784101500/ ln 63095665, trilogy acetabular liner/ pn 00630505636/ ln 63175336 , shell porous with cluster holes 56 mm o.D.00620005622/ln 63043707.Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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.Not returned to manufacturer.
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It was reported that patient had a hip revision approximately 16 months post implantation due to pain, loosening of femoral stem and acetabular cup, infection, and dislocation.Attempts have been made and additional information on the reported event is unavailable.
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