(b)(4).Medical product: catalog #: 00434901413, humeral stem 14 mm stem, lot # 62908449.Catalog #: 00434906606, retentive poly liner plus, lot # 03594043pe.Catalog #: 00434901500, base plate 15 mm post length uncemented, lot # 62926996.Visual examination of the provided pictures identified that all devices are explanted.Stem has bone tissue on the porous shaft.Poly liner is damaged on the bottom and has blood tissue.Glenosphere was explanted.On the x-rays is showed previous bone loss, ho, and instability.It also noted good position, no impingement, evidence stress shielding noted on the proximal anterolateral.Device history record was reviewed and no discrepancies relevant to the reported event were found.A definitive root cause could not 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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2020-00562, 0001822565-2020-00563.
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It was reported that the patient underwent an initial revision of the left shoulder due to instability.Subsequently patient experienced subluxation and underwent closed reduction, pain, instability and underwent a second revision due to liner disassociation.No additional information is available form the event.
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