(b)(4), this follow-up report is being submitted to relay additional information.No product was returned or pictures provided; visual and dimensional evaluations could not be performed.Review of the device history records identified no deviations or anomalies during manufacturing for the shell.Medical records were not provided.It was reported that the shell was inserted first and then the screw hole covers were attempted to be removed.Per the g7 acetabular surgical technique on page 18, the screw hole covers should be removed using the hex driver prior to shell insertion.This could have been a contributing factor to the screw hole covers not coming out of the shell.However, due to the lack of pictures, the screw driver stripping while attempting to remove the screw hole covers, and the covers eventually coming out with the shell being implanted, a definitive root cause cannot be identified.This complaint cannot be confirmed.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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