The product was not returned for evaluation; hospital discarded as biohazard.Reported event was unable to be confirmed due to limited information received from the customer.Device history record was reviewed and no discrepancies were found.Review of the complaint history determined that no further action is required as no trends were identified.Root cause was unable to be determined as the necessary information to adequately investigate the reported event was not provided.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: under possible adverse effects: improper selection, placement, positioning, and fixation of the device can lead to failure of the device or the procedure.The surgeon is to be familiar with the device, the method of application and the surgical procedure prior to performing surgery.The surgeon must select a type or types of internal fixation devices appropriate for treatment.Dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.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: 1825034 ¿ 2017 ¿ 09215 / 09216.This report is being submitted late as it has been identified in remediation.
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It was reported that the patient underwent right total hip arthroplasty on (b)(6) 2015 at which time a bipolar hip was implanted.Subsequently, the patient was revised on (b)(6) 2015 due to dislocation as result of loose abductor muscles and a greater trochanteric fracture.During the procedure, the surgeon drilled through the drill guide and placed a 2.9 juggerknot anchor.The surgeon attempted to place a second anchor but it pulled out.The surgeon then tried to seat another anchor but it pulled out as well.On the third attempt the juggerknot anchor held and the surgeon was able to make the soft tissue repair.No additional holes were drilled.During the surgery, the bipolar cup was also removed and replaced by an endo head.
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