(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2024 - 00432; 0001825034 - 2024 - 00433; 0001825034 - 2024 - 00434.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Complaint confirmed based on the evaluation of the medical records.Part and lot identification are necessary for review of device history records, neither were provided.Medical records were provided and identified the following: extensive soft tissue damage and debris from metal wear, 90% of abductors chronically torn and damaged.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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It was reported that the patient underwent a revision approximately eighteen years post implantation due to pain, metal artifact, fluid collection, and tendon tears.During the procedure, extensive soft tissue damage, debris from metal wear, and torn/damaged abductors were noted.The cup, head, and liner were exchanged without complication.The stem remained implanted.Attempts have been made and no further information has been provided.
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