Catalog Number UNKNOWN |
Device Problems
Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374)
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Event Date 08/08/2023 |
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: 0001825034-2023-02662, 0001825034-2024-00886; 0001825034-2024-00888; 0001825034-2024-00889; 0001825034-2024-00890.D10: compr vrs glen pps min tpr adr cat: 110027734 lot : 66157394.Unknown screw qty 2.Unknown glenosphere.Unknown bearing.G2: foreign: japan.Customer has indicated that the product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up report will be submitted.H3 other text : product not returned.
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Event Description
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It was reported patient was revised due to fracture of the glenoid and dislocation of the bearing and glenopshere approximately 5 months post implantation.No additional patient consequences were reported.Attempts have been made and additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Upon further review it has been determined that the device was previously investigated on medwatch#: 0001825034-2024-00930.This file will be considered not reportable.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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Upon further review it has been determined that the device was previously investigated on medwatch#: 0001825034-2024-00930.This file will be considered not reportable.
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Search Alerts/Recalls
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