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Model Number N/A |
Device Problems
Material Erosion (1214); Activation, Positioning or Separation Problem (2906)
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Patient Problems
Pain (1994); Scar Tissue (2060); Metal Related Pathology (4530)
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Event Date 08/24/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).D10: cat# 139254 lot# 708230 m2a-magnum 42-50mm tpr insrt-3 0/-3mmt1.Cat# us157852 lot# 720260 m2a-magnum pf cup 52odx46id.Cat# 103206 lot# 731470 taperloc por fmrl 12.5x145.Product will not be returned to zimmer biomet for investigation.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2024-00857, 0001825034-2024-00858.
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Event Description
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It was reported that approximately 16 years post implantation of a left total hip arthroplasty, the patient was revised for concern of metallosis development and pain.During the revision, it was reported that the femoral head was extremely hard to remove as it was cold welded to the trunnion.A substantial amount of scar tissue was also removed from the hip joint.There were no surgical complications.No additional information was available.
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Search Alerts/Recalls
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