(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the product location is unknown.Concomitant medical products: item number: unknown, item name: unknown head, lot #: unknown, item number: unknown, item name: unknown stem, lot #: unknown.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2018 - 10829.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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It was reported patient was revised approximately 15 years post-implantation due to pain, osteolysis, neurological issues, and elevated cobalt and chromium levels.Attempts have been made and no additional information is available.
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