Model Number N/A |
Device Problems
Mechanical Problem (1384); Device Dislodged or Dislocated (2923); Unintended Movement (3026)
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Patient Problem
Insufficient Information (4580)
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Event Date 01/25/2022 |
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.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: a patient underwent an initial knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to instability was performed on unknown (b)(6) 2022.Original oxford (b)(6) 2020, is well fixed, but patient has become unstable.Previous prostheses information attached to this booking.Medium right 5 bearing removed.Medium right 7 bearing inserted.
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Manufacturer Narrative
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(b)(4).This follow-up report is being submitted to relay additional information.Additional information received: the explanted item details have now been correctly confirmed as: description: oxf anat brg rt md size 5 pma item: 159577 lot: 6641092.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: a patient underwent an initial knee arthroplasty.Subsequently, a revision procedure due to instability was performed.Original oxford is well fixed, but patient has become unstable.Medium right 5 bearing removed.Medium right 7 bearing inserted.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: the product has not been returned for evaluation, therefore the investigation has been limited to the information provided, a review of the device history records, and a complaint history search.The device is used for treatment.X-rays or medical notes have not been provided.A dhr review identified no deviations or anomalies during manufacturing that could be related to the reported event.A review of complaint history identified no additional similar complaints about the reported item number, and no additional complaints for the same item and lot combination for 3 years prior to the notification date.It has been confirmed that the item is not within the scope or subject of any field actions or recalls which could be attributed to the reported event.Without the opportunity to examine the complaint item, a definitive root cause cannot be determined due to insufficient information.Corrective action and/or preventative action: no corrective or preventive action is required at this time.If any additional information is discovered or received that may adjust any conclusions or data, a supplemental report will be rendered accordingly.Zimmer biomet will continue to monitor for trends.
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Event Description
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It was reported, that: a patient underwent an initial knee arthroplasty on (b)(6) 2020.Subsequently, a revision procedure due to instability was performed on (b)(6) 2022.Medium right 5 bearing removed.Medium right 7 bearing inserted.Patient height and weight are not available.
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Search Alerts/Recalls
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