(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product remains implanted.Udi: (b)(4).Concomitant medical products: item number: xl-200150, item name: active articulation head, lot #: 981030; item number: 163666, item name: femoral head bearing, lot #: 553980; item number: 110017105, item name: g7 shell, lot #: 366265; item number: 51-107140, item name: taperloc stem, lot #: 3612807.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 08165, 0001825034 - 2018 - 08166.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
|
It was reported that patient was hospitalized approximately 2 weeks post revision surgery due to excessive bleeding/delayed wound healing.The patient was taken into surgery the next day due to experiencing pain, and loosening.During the surgery, a mass filled with fluid was removed and a wound vac system was inserted.
|
Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies relevant to the reported event 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2019 - 01184, 0001825034 - 2019 - 01185.
|