Model Number N/A |
Device Problem
Patient Device Interaction Problem (4001)
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Patient Problem
Implant Pain (4561)
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Event Date 01/06/2022 |
Event Type
Injury
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Event Description
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It was reported, that: it was reported that a patient underwent an initial right knee arthroplasty on an unknown date.Subsequently, the small right 4mm bearing was removed on (b)(6) 2022 as the metal x-ray marker came out of the bearing and was irritating the patient's soft tissues.Bearing was removed and replace with a new bearing of the same size.Patient involvement - revision.
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Manufacturer Narrative
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(b)(4).Initial report.Customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded by the user facility.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 right knee arthroplasty on an unknown date.Subsequently, the small right 4mm bearing was removed on jan 06, 2022, as the metal x-ray marker came out of the bearing and was irritating the patient's soft tissues.The bearing was removed and replaced with a new bearing of the same size.Patient involvement - revision.
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Manufacturer Narrative
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(b)(4).This final report is being submitted to relay supplemental information.Complaint summary: no product was returned; visual and dimensional evaluations could not be performed.The photograph and x-ray provided show that the x-ray marker is out of the bearing.A review of the device history record identified no related deviations or anomalies during manufacturing.This device is used for treatment.The reported event is not related to a combination of products; therefore, a compatibility review is not applicable.A review of complaint history found no additional related issues for this item and the reported part and lot combination.The photograph provided confirms that the x-ray marker is out of the bearing.Medical records have not been provided.No corrective/preventive actions are needed at this time.This complaint was determined not to be a new confirmed quality or manufacturing issue.Complaints are monitored through monthly complaint reviews in order to identify potential adverse trends.A warm tool is used to seal the wire in the bearing and without the product being returned we cannot check exactly what caused the wire to come out.Hence, a root cause cannot be determined.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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Search Alerts/Recalls
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