Catalog Number 00434906603 |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 09/21/2023 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: glenosphere eccentric 40 mm diameter +3 mm lateral offset cat#00436304025 lot#64423332.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.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2023 - 02723.
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Event Description
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It was reported that a patient underwent a revision procedure approximately 13 months post implantation due to dislocation.The poly liner, glenosphere, and tray were replaced.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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This follow-up report is being submitted to relay additional information.D10: 9mm humeral stem spacer cat#: 00434903909, lot#: 65341647.The reported event is not confirmed.The returned product shows damage on the products, but there are no medical records or x-rays to confirm disassociation or dislocation.Visual examination of the returned product identified the poly liner shows damage in the spherical radius and backside.Dhr shows the mating features that accept the poly liner are 100% inspected on a cmm at the time of manufacture ¿ all devices were conforming to print specifications.Review of the device history record(s) identified no deviations or anomalies during manufacturing related to the reported event.A definitive root cause cannot 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: 0001822565-2024-00462.
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Event Description
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No further event information is available at the time of this report.
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Search Alerts/Recalls
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