It was reported that the patient underwent a hip arthroplasty.Subsequently, the patient underwent a revision of the hip prosthesis one month post implantation due to loosening of the tantalum cup.It was reported that when removing the cup, a screw was passed through at one of the holes in the cup.
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This follow-up report is being submitted to relay additional and/or corrected information.Updated: g3, g6, h2, h3, h6.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 for the screw.Complaint history review cannot be performed without product identification for the screw.Medical records were not provided.A definitive root cause cannot be determined.This complaint cannot be confirmed.If any further information is found which would change or alter any conclusions or information, a supplemental report will be filed accordingly.Zimmer biomet will continue to monitor for trends.
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