Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problems
Unspecified Infection (1930); Osteolysis (2377)
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Event Date 03/27/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: mfr#0001822565-2018-02092, mfr#0001822565-2018-02093.Concomitant medical products: bigliani/flatow glenoid component pn00430008200 ln60919038 trabecular metal humeral stem pn00434811713 ln61665209.Foreign report source- (b)(6).Reported event was unable to be confirmed due to limited information received from the customer.Dhr was reviewed and no discrepancies were found.Review of sterilization certification confirms devices were sterilized in accordance with iso 11137-2.Review of the complaint history determined that no further action is required as no were trends identified.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.
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Event Description
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It was reported that the patient underwent an initial left total shoulder arthroplasty.Subsequently, the patient underwent revision two years later due to infection and osteolysis.All implants were removed and a spacer was inserted.The surgeon intends to implant a total reverse shoulder in 6 weeks.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Upon reassessment of the reported event, it was determined that this device was not involved in the event.The initial report was submitted in error and should be voided.
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Search Alerts/Recalls
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