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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).Concomitant medical devices: unknown-unknown, cup-unknown; unknown-unknown, liner-unknown; unknown-unknown, stem-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001822565 - 2020 - 04076, 0001822565 - 2020 - 04078, 0001822565 - 2020 - 04079.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Product remains implanted.
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Event Description
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It was reported that the patient has possibly experienced a superficial joint infection on an unknown date.No revision has been reported.Attempts have been made and additional information on the reported event is unavailable at this time.
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Event Description
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Upon receipt of additional information, it has been determined that these hip implants were not zimmer biomet, therefor we do not have reporting responsibility.The initial report was submitted in an error and should be voided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Upon receipt of additional information, it has been determined that these hip implants were not zimmer biomet, therefor we do not have reporting responsibility.The initial report was submitted in an error and should be voided.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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