Model Number N/A |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Pain (1994); Reaction (2414); Metal Related Pathology (4530)
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Event Date 12/28/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical devices: item number us157856 item name m2a-magnum pf cup 56odx50id lot # 815320; item number 11-103204 item name taperloc por fmrl lat 10x140 lot # 906780.The device will not be returned for analysis due to hospital policy; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 00077.
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Event Description
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It was reported that patient underwent right total hip arthroplasty.Subsequently, patient was revised 12 years later due to pain.Metallosis was found during the revision but not enough to take the stem.The head and taper adapter were removed and replaced with active articulation devices.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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No further event information available at the time of this report.
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Manufacturer Narrative
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d10: item number 11-103204 item name taperloc por fmrl lat 10x140 lot # 906780 item number 139254 item name m2a-magnum 42-50mm tprinsrt-3 lot # 312640 no product was returned or pictures provided; visual and dimensional evaluations could not be performed.A review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Medical records were not provided.A definitive root cause cannot be determined. 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. multiple mdr reports were filed for this event, please see associated reports: 0001825034-2021-01275.
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Search Alerts/Recalls
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