(b)(4) initial report.Additional information, including device lot codes, post primary and pre revision x-rays, operative notes, patient details, patient medical history and an update on the patient post revision has been requested in order to progress with the investigation of this event, and if received, will be provided in a supplemental report upon completion of the investigation.The explanted devices are available and are being returned to corin for examination.Upon receipt of the appropriate device details, the relevant device manufacturing records will be identified and reviewed.
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Per -3453 final report.Additional information, including device lot codes, post primary and pre revision x-rays, operative notes, patient details, patient medical history and an update on the patient post revision was requested in order to progress with the investigation of this event, however, none of this information was provided and thus the scope of the investigation was limited.The explanted devices were returned to corin and examined.During this review the lot code of the associated head could be identified but the lot code on the liner was unreadable.The relevant device manufacturing records for the associated head have been identified and reviewed.All parts associated with this record conformed to material and dimensional specification at the time of manufacture.Based on the available information and from review of the explanted devices it has been concluded that the liner dislodged from the cup when the patient was reportedly moving their leg in a circumduction movement.This then led to the head articulating against the rim of the liner and inner surface of the shell, causing excessive wear to the poly.Therefore, this case is now considered closed, however, should any additional information be provided then this case may be re-opened for further investigation.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative or distributor caused or contributed to this event.
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