Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
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Patient Problems
Fall (1848); Joint Dislocation (2374)
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Event Date 03/04/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unk stem, unk head.Foreign: country: (b)(6).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 mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-00670, 0001825034-2022-00671.
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Event Description
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It was reported that the patient underwent an initial hip arthroplasty on an unknown date.Subsequently, the patient dislocated hip due to stem subsiding and patient fall.Patient was revised.No additional information.
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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) review was unable to be performed as the lot number of the device involved in the event is unknown.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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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