(b)(4).Multiple mdr reports were filed for this event, please see associated reports: 0001822565-2023-01419.The customer has indicated that the product will not be returned to zimmer biomet for investigation as it was discarded.The investigation is in process.Once the investigation has been completed, a follow-up mdr will be submitted.
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Proposed component code: mechanical (g04)- head.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Lot identification is necessary for review of device history records, lot identification was not provided.Medical records were provided and reviewed by a health care professional.Review of the available records identified the following: an initial left tha was performed on an unknown date.In an office, the patient reported pain, recurrent dislocations, instability, and the need to use a cane to ambulate.A revision was performed where the head and liner were explanted and replaced with zb products.Radiographs were provided and reviewed by a health care professional.Review of the available records identified the following: normal appearance of left total hip arthroplasty.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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