Patient was revised to address cup loosening and pain.Update rec'd 03/07/2014: patient's medical records were received.Records indicate upon revision it was noticed the patient had metallosis from where the loose screws and triflange cup were meeting with a resultant pseudotumor formation.Upon removal of the acetabular cup a low transverse fracture created a pelvic disassociation.Also noted, was a screw that had migrated medially and one that was broken and retained in the ilium due to osteolysis.At this time it is unknown which screw had migrated and which had broken.Doi: (b)(6) 2011 dor: (b)(6) 2014 (right hip).The devices associated with this report were not returned.A review of the device history records for the d5ldl1000, d13pk1000 and c4gde1000 lot codes did not reveal any related manufacturing deviations or anomalies.A complaint database search finds no other related incidents against the remaining product and lot combinations.Requests for additional investigational inputs were made in accordance with wi-(b)(4) appendix a.Medical records were obtained and reviewed by a medical professional.From a medical perspective based on the information available, it is unlikely the complaint is product related.The investigation could not verify or identify any product contribution to the reported event with the information provided.Based on the inability to identify root cause, the need for corrective action was not indicated.Depuy considers the investigation closed.Should additional information be received, the information will be reviewed and the investigation will be re-opened as necessary.
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