Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problem
Unspecified Infection (1930)
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Event Date 04/08/2022 |
Event Type
Injury
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Event Description
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It was reported that a patient underwent a hip revision after an unknown amount of time post implantation due to infection.All component were removed and replaced with an antibiotic spacer.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 product 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: 0001822565 -2022 -01255, 0001822565 -2022 -01256, 0001822565 -2022 -01257.
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Event Description
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No additional event information to report at this time.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.H6: component code mechanical (g04) - stem.Reported event was unable to be confirmed due to limited information provided by the customer.Part and lot identification 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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Search Alerts/Recalls
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