Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Metal Related Pathology (4530); Swelling/ Edema (4577)
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Event Date 10/01/2020 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: catalog number:us157852 lot number:213320 brand name: m2a-magnum pf cup.Catalog number:157446 lot number: 368600 brand name:m2a-magnum mod hd.Catalog number:139252 lot number:688380 brand name: m2a-magnum 42-50mm.Catalog number:192413 lot number: 607420 brand name: echo por fmrl red.Multiple reports were submitted along with this report 0001825034-2022-00633, 0001825034-2022-00635.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 was revised due to pain, effusion and metallosis approximately 10 years post implantation.Additional information on the reported event is unavailable.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Reported event was confirmed via medical records reviewed by a health care professional.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history record(s) identified no deviations or anomalies during manufacturing.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.
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Event Description
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No additional information on the reported event.
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Search Alerts/Recalls
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