Catalog Number UNKNOWN BEARING |
Device Problem
Unstable (1667)
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Patient Problem
Insufficient Information (4580)
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Event Date 12/08/2023 |
Event Type
Injury
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Event Description
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It was reported that the patient underwent a revision surgery approximately eight (8) months post-implantation due to instability.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2023-03087.D10: item# unknown glenosphere; lot# unknown.E1: full establishment name - sp zoz centralny szpital kliniczny uniwersytetu medycznego w lodzi.G2: foreign - event occurred in poland.Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.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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No further event information available at the time of this report.
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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.Medical records were not provided.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.If any further information which 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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