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Per comp 2377 initial report: additional information including: post primary and pre revision x-rays.Photographs of the explanted device.Operative notes (primary and revision).Patient weight, activity level and medical history.Did the patient follow correct post-op protocol? did the patient experience any slips / falls or other trauma post primary surgery? an update on the patient post revision.Any patient specific anatomies which may have impacted the cup orientation.Any specific patient activities which would lead to extreme range of motion.Whether there was any damage noted on the stem during the revision? was this an ops patient - were any issues with dislocation/ impingement anticipated? why was an epw liner chosen for this patient? what position was the elevated wall placed? 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 relevant device manufacturing records will be identified and reviewed.Conclusions will be provided in a supplemental report.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occured outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative of distributor caused or contributed to this event.
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Per (b)(4) final report:
the following additional information was requested to aid the investigation of this event - post primary and pre revision x-rays, photographs of the explanted device, operative notes (primary and revision), patient weight, activity level and medical history, whether the patient followed correct post-op protocol, whether the patient experienced any slips / falls or other trauma post primary, surgery, an update on the patient post revision, any patient specific anatomies which may have impacted the cup orientation, any specific patient activities which would lead to extreme range of motion, whether there was any damage noted on the stem during the revision, was this an ops patient - were any issues with dislocation/ impingement anticipated, why was an epw liner chosen for this patient and what position was the elevated wall placed.Not all requested information could be provided due to patient confidentiality.It was unknown whether the patient had experienced any slips / falls or other trauma and also unknown whether they had followed correct post-op protocol.X-rays were provided and the explanted devices were also returned for examination.The relevant device manufacturing records were be identified and reviewed.All finished parts associated with these records conformed to material and dimensional specification at the time of manufacture.Review of these records revealed no product non-conformity or deviation from process that would have caused or contributed to this event.Based on the available information, review of the manufacturing records and information regarding the event provided by the reporter, it has been concluded that the most likely that the event is linked to patient activity.The failure appears to have occurred whist the patient may have been carrying additional weight.Please note: this report is filed with the fda due to an adverse event experienced with a device that is similar to those placed on the market in the usa, however, this event occurred outside of the usa.The submission of this report does not constitute an admission that the device, reporting entity, entity's representative of distributor caused or contributed to this event.
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