The complaint product return was requested and not returned for evaluation.Review of dhr found no deviations or anomalies.Review of complaint history identified additional issues associated with this lot and item, no adverse trends noted.The root cause was not determined and the complaint was not confirmed.There are warnings in the package insert that this type of event can occur and risks are addressed in risk documentation.Under possible adverse effects, number 4 states, ¿loosening or migration of the implants may occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ following review, no new risks were identified.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: 0001825034-2014-07866 and 0001825034-2017-07932.
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It was reported that patient underwent a total hip arthroplasty on (b)(6) 2007.Subsequently, patient was revised on (b)(6) 2014 due to acetabular loosening.During the procedure there was trouble disassociating the head from the stem, however, there was no delay as a result.The procedure was completed using competitor products.No additional patient consequences were reported.
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