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It was reported that left hip revision surgery was performed.During the revision, the bhr head was removed.The bhr cup remained implanted.As of today, the implanted devices, all of which were used in treatment, and additional information have been requested for this complaint but have not become available.A review of the complaint history for the bhr cup and bhr head was performed using batch numbers in search of similar recurring reports for the products during their lifetimes.No other similar complaints were identified for the bhr cup.Similar complaints have been identified for the bhr head and this will continue to be monitored.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.All the released devices involved met manufacturing specifications at the time of production.Review of the product ifu found adequate warnings and precautions in relation to the alleged failure modes.A risk management review was performed.No additional risks were identified as result of the reported event and no further actions are required at this time.The available medical documents were reviewed.The periprosthetic fracture and subsequent revision were likely related to the patient fall and is not associated with a malperformance of the implant.Although the surgeon noted retroacetabular bone loss and soft tissue mass believed to be an adverse local tissue reaction prior to revision, no findings were noted intraoperatively.Without supporting lab/pathology results, imaging, and/or the analysis of the explanted components, the bone loss and adverse local tissue reaction cannot be confirmed.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.Without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint.Based on the available information, a root cause of an adverse incident has been selected due to the fall.If the products or additional information become available in the future, this case will be re-opened.No preventative or corrective action has been initiated as a result of this investigation.
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