Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923); Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Unspecified Infection (1930); Nerve Damage (1979); Joint Dislocation (2374); Peripheral Nervous Injury (4414)
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Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2023 - 02586; 0001825034 - 2023 - 02587; 0001825034 - 2023 - 02588.
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Event Description
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It was reported in a surgeon survey involving the comprehensive segmental revision system that an unknown number of patients experienced complications including dislocation, instability, infection, and nerve irritation/palsy post implantation.No further details were provided concerning the number of complications or correlation to a surgical case.Attempts have been made and additional information on the reported event is unavailable at this time.
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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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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.Part and lot identification are necessary for review of device history records, neither were provided.A definitive root cause cannot be determined.The reported event is unconfirmed.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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Search Alerts/Recalls
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