Catalog Number 00435006500 |
Device Problems
Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)
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Patient Problems
Joint Dislocation (2374); Insufficient Information (4580)
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Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision procedure due to dislocation approximately four years post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 -2023 -02154.D10: comp rvrs shldr glnsp std 36mm cat: 115310 lot: j7571012.25mm versa-dial taper adaptor cat: 118000 lot: j7500817.It is unknown if product will be returning to zimmer biomet and the investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.
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Event Description
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It was further reported that the patient was revised due to disassociation.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history record(s) identified no deviations or anomalies during manufacturing.Further information received indicates that the patient was revised due to disassociation.Therefore, this product did not cause or contribute to the reported event and should be considered not reportable.The event is addressed on 0001825034-2023-02154.The reported event is unconfirmed.If any further information is found that would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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