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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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Manufacturer Narrative
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(b)(4).D10: unknown taperloc stem unknown.Unknown g7 cup unknown.Unknown head unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00456, 0001825034-2024-00457, 0001825034-2024-00458.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.
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Event Description
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It was reported the patient was implanted with a taperloc stem and g7 cup on an unknown date.Subsequently, the patient was revised on an unknown date due to infection.The head and liner were exchanged.The patient was revised a second time, and all implants were removed, and the patient was implanted with g21 hip cement spacer.The spacer was removed, and the patient was implanted with arcos with g7.Attempts have been made and no further information has been provided.
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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 and/or corrected information.No product was returned, or pictures provided; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were provided.Complaint history review cannot be performed without product identification.Medical records were not provided.A definitive root cause cannot be determined.Single-use, sterilized devices manufactured or distributed by zimmer biomet are sterilized in accordance with fda regulations and iso standards to a sterility assurance level.Therefore, it is unlikely that the specified device caused any patient infection.Unable to confirm complaint as no product information or medical records were provided.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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Search Alerts/Recalls
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