Model Number N/A |
Device Problems
Corroded (1131); Material Erosion (1214)
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Patient Problems
Pain (1994); Scar Tissue (2060); Reaction (2414)
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Event Date 04/02/2018 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).The device will not be returned for analysis, as the device location is unknown; however, an investigation of the reported event is in progress.Once the investigation is completed, a supplemental medwatch 3500a will be submitted.Concomitant medical products: cat# 00801803203 femoral head lot# 61409524.Cat# 00620005822 shell porous with cluster holes 58 lot# 61407910.Cat# 00631005832 liner 10 degree elevated lot# 61375210.Cat# 00625006530 bone scr 6.5x30 self-tap lot# 61422326.Multiple mdr reports were filed for this event, please see associated reports: 0002648920-2020-00447.
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Event Description
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It was reported a patient had underwent a left hip revision approximately 8 years post implantation due to elevated metal ion levels, pain, in-vivo corrosion, and scar tissue.No additional information.
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Manufacturer Narrative
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D7: should be blank as the device remains implanted.The reported event was confirmed by review of medical records noting patient had elevated metal ion levels.Scar tissue was excised from the wound during the procedure and there was corrosion at the head-trunnion interface.No evidence of alval was found.The head was removed and replaced.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.
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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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Search Alerts/Recalls
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