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Model Number N/A |
Device Problem
Corroded (1131)
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Patient Problems
Pain (1994); Local Reaction (2035); Osteolysis (2377)
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Event Date 06/22/2016 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Concomitant medical products: biomet m2a magnum tpr adpr ti dia52-6 0/0mmt1 cat#139268 lot#201540.Biomet m2a-magnum pf cup 62odx56id cat# us157862 lot# 305750.Biomet m2a-magnum mod hd sz 56mm cat# 157456 lot# 297070.Complaint was confirmed by op notes which indicated patient was revised due to metallosis.Upon opening, thick fibrotic avascular tissue consistent with an acute local tissue reaction was noted.The density of the fibrotic scar tissue had eroded the proximal femur and resulted in impingement anteriorly.Review of the device history records identified deviations or anomalies during manufacturing, the deviations or anomalies would not have attributed to the event.Root cause was unable to 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: 0001825034-2017-02396, 0001825034-2017-02395, 0001825034-2020-02230.
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Event Description
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It was reported that patient was revised approximately 5 years post-implantation due to pain, metallosis, impingement, altr, and elevated metal ion levels.No further event information available at the time of this report.
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Search Alerts/Recalls
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