(b)(4).Customer has indicated that the product will not be returned to zimmer biomet for investigation, as the hospital does not allow return of product.The investigation is in process.Once the investigation is completed, a follow up mdr will be submitted.Medical devices: item # 110010265 g7 osseoti shell lot # 3873241, item # 110024464 g7 dual mobility liner lot # 994580.Hospital does not allow return of product as recorded by sales rep.Multiple mdr reports were filed for this event, please see associated reports: 0001825034-2018-00420, 00421, 00512, 00513.00514, 00515, 00516, 00517, 00518, 00519.Hospital doesn't allow return of product.
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It was reported that the patient underwent a revision surgery for disassociation less than thirty days post initial total hip replacement.Due to the patient's pre-existing condition, eight screws were used to implant the shell.However, the screws backed out of the shell, and pushed the liner out causing the disassociation.Due to the poor bone quality and failing health of the patient, all implants were removed.Attempts have been made, and no further information available.
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