(b)(4).No product was returned or pictures provided; 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 were provided and reviewed by a health care professional.Review of the available records identified the following: pain, debris from metallosis, scar tissue and adhesions debrided, acetabular gross loosening and inverted 180 degrees, unable to remove taper/head due to cold weld, noted bone insufficiency from osteolysis, no 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.Multiple mdr reports were filed for this event, please see associated reports: 0001825034 - 2021 - 02085, 0001825034 - 2021 - 02086, 0001825034 - 2021 - 02084.
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