(b)(4).Concomitant medical devices: 11-173660 ¿ m2a 38 head ¿ 971360; 15-105050 ¿ m2a shell 0 993340.Reported event was confirmed by review of medical records noting severe right hip pain with high cobalt and chromium metal ion levels.Synovectomy and capsulectomy performed.The head component was returned and evaluated against the reported event.Visual inspection found scuffing and wear on the outer radius consistent with metal on metal construction.A few dings were observed around the rim of the head.A tool mark was found on the outer radius.Black debris is present inside the taper of the head.Sem analysis found the taper of the head was reviewed with optical microscopy.Taper was assigned a modified goldberg score of 4.A score of 4 corresponds to damage over majority of the surface with severe corrosion and corrosion debris.Dhr was reviewed and no discrepancies were found.The root cause is 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 - 2018 - 02151.
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It was reported that patient underwent a right hip revision approximately 12 years post implantation due to pain, metallosis, noise, and elevated metal ion levels.The head component was removed and replaced.Attempts have been made and additional information on the reported event is unavailable at this time.
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