Model Number N/A |
Device Problems
Unstable (1667); Device Dislodged or Dislocated (2923)
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Patient Problem
Joint Dislocation (2374)
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Event Date 08/02/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the device location is unknown.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Concomitant medical product: part: 650-1058, lot: 2020050068, cer bioloxd option hd 40mm.Report source: (b)(6).
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Event Description
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It was reported that the patient was revised for dislocation and instability.The head and liner were exchanged.Attempts to obtain additional information have been made; however, no more is available at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was unable to be confirmed due to limited information received from the customer.Device history record (dhr) was reviewed and no discrepancies were found.Root cause was unable to 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.
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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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Search Alerts/Recalls
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