Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Inflammation (1932); Pain (1994)
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Event Date 09/27/2021 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Initial report.Report source, foreign - event occurred in (b)(6).Customer has indicated that the product will not be returned to zimmer biomet for investigation due to hospital policy.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 that the patient is having a primary total hip replacement and a revision of an oxford unicompartmental knee replacement on the same side (right).The patient had issues of pain and inflammation on the right knee, hence he decided to have it revised at the same time as his hip.
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Event Description
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It was reported that the patient is having a primary total hip replacement and a revision of an oxford unicompartmental knee replacement on the same side (right).The patient had issues of pain and inflammation on the right knee, hence he decided to have it revised at the same time as his hip.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay additional information.Complaint summary: product has not been returned for evaluation.X-rays or medical notes have not been provided.The investigation has been limited to the information provided, a review of the device history records, and a complaint history search.Review of the device history records identified no deviations or anomalies during manufacturing that could be related to the reported event.Review of complaint history identified additional similar complaints for the reported item and no additional complaints for the reported item and lot combination.This device is used for treatment.Not enough information has been provided to determine if all implants are compatible.These part and lot combinations are not associated with any recalls at the time the search was conducted.The likely condition of the device when it left zimmer biomet is conforming to specification.The root cause of the reported event is likely to be disease progression, which is not considered device related.No corrective action required at this time as the root cause of the reported event is not device related.If any further information is found which would change or alter any conclusions or information, a supplemental will be submitted accordingly.Zimmer biomet will continue to monitor for trends.H3 other text : hospital policy.
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Search Alerts/Recalls
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