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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Pain (1994); Loss of Range of Motion (2032); Metal Related Pathology (4530)
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Event Date 03/30/2022 |
Event Type
Injury
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Event Description
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It was reported patient underwent a right hip revision approximately 11 years post implantation due to pain, elevated cobalt and chromium levels, decreased adls, and limited mobility.During revision, evidence of metallosis was observed as well as failure of a previously repaired abductor muscle.The femoral head was cold-welded to the femoral trunnion, the head was removed with a metal cutting burr and no damage to the trunnion occurred.The acetabular component and femoral stem were left implanted.The procedure was completed without further complication.Attempts have been made and additional information on the reported event is unavailable at this time.
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Manufacturer Narrative
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(b)(4).Concomitant medical products: unknown-unknown m2a cocr 44mm-6 head-unknown.Unknown-unknown taper-unknown.Unknown-unknown biomet mallory 8mm lateralized stem-unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2022 - 01889, 0001825034 - 2022 - 01891.Customer has indicated that the product will not be returned to zimmer biomet for investigation, product remains implanted.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Device remains implanted.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.Complaint confirmed via medical records and radiographs that were provided and reviewed by a health care professional.No product was returned; visual and dimensional evaluations could not be performed.Part and lot identification are necessary for review of device history records, neither were 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.
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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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