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Model Number N/A |
Device Problem
Material Erosion (1214)
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Patient Problems
Failure of Implant (1924); Pain (1994); Osteolysis (2377); Ambulation Difficulties (2544); Metal Related Pathology (4530); Muscle/Tendon Damage (4532)
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Event Date 12/07/2022 |
Event Type
Injury
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Manufacturer Narrative
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(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-00431.Concomitant medical product: unk size 56 mm durom lbh metal on metal non ha coated cup.Unk metal acetabular liner.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it has been discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Event Description
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It was reported initial right total hip arthroplasty that was subsequently revised approximately fifteen (15) years later due to pain, ambulation difficulty, elevated metal ions, and osteolysis.During the procedure noted soft tissue damage and metallosis.An osteotomy was performed to remove the stem.The head, stem and bearing were exchanged without complications.The cup remained implanted.Attempts have been made and no further information has been provided.
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Manufacturer Narrative
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This follow-up report is being submitted to relay additional information.The following sections were {update/corrected} mechanical (g04) ¿ head 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.Medical records/radiographs were provided and reviewed by a health care professional.A review of the available records identified findings of the reported issues left knee pain, swelling, osteolysis, lab results, soft tissue destruction, metallosis, no other complications.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 further information at the time of this report.
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Search Alerts/Recalls
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