Model Number N/A |
Device Problem
Insufficient Information (3190)
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Patient Problem
Insufficient Information (4580)
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Event Date 05/26/2022 |
Event Type
Injury
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Event Description
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It was reported that patient underwent a left hip revision after an unknown amount of time post implantation due to unknown reasons.The head and stem were replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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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 the 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2022-01491.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were updated/corrected updated: g3; h2; h6 h6: component code mechanical (g04) ¿ stem the reported event is unable to be confirmed due to limited information provided by the customer.Part and lot identification of stem are necessary for review of device history records, neither were provided.A definitive root cause could not 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 additional event information to report at this time.
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Search Alerts/Recalls
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