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 Type
Injury
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Event Description
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It was reported in a journal article that one patient within a taperloc full profile group underwent debridement, antibiotics, irrigation and retention (dair) procedure after an unknown amount of time post total hip arthroplasty due to infection.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).Report source (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for the investigation as the product remains implanted.The investigation is in process and a follow-up mdr will be submitted upon completion.Multiple mdr reports were filed for this event, please see associated reports 0001825034 - 2022 - 00512, 0001825034 - 2022 - 00513, 0001825034 - 2022 - 00514.Doi 10.2340/17453674.2021.1127.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The reported event is unable to be confirmed due to limited information provided by the customer.The dhr was unable to be reviewed as the lot number for the device is unknown.The root cause is 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 additional event information to report at this time.
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Search Alerts/Recalls
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