Model Number 110031428 |
Device Problem
Detachment of Device or Device Component (2907)
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Patient Problem
Failure of Implant (1924)
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Event Date 08/15/2022 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2022-02637.Medical products: item#: 110031428, bearing +3 mm thickness 40 mm diameter; lot#: 65163939.Item#: 110031405, mini tray std cocr +6 offset; lot#: 65075707.Customer has indicated that the product is in process of being returned to zimmer biomet for investigation.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported that a patient was undergoing an initial shoulder arthroplasty.During implantation of the first implant, the polyethylene disassociated and was explanted.A second polyethylene implant was used and this implant disassociated as well.A third polyethylene implant was implanted and it was implanted successfully.There was no patient injury as a result of the malfunction.
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Event Description
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It was reported that this event was previously reported.The event was reported under mfr number 0001822565-2022-02574.Therefore, this initial medwatch was submitted in error and should be voided.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay corrected information.The following sections were updated: b4; b5; g3; g6; h1; h2.Upon receiving additional information of the reported event, it was determined that the product was previously reported under this mfr number 0001822565-2022-02574.The initial report should be voided.
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Search Alerts/Recalls
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