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It was reported that left hip revision surgery was performed.As of today, the implanted devices, all of which were used in treatment, and additional information has been requested for this complaint but has not become available.A review of the complaint history for the head/ sleeve/ stem 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 head / stem.Similar complaints have been identified for the sleeve.However, as the device is no longer sold, no action is to be taken.In the absence of the actual devices, the production records were reviewed for the devices reportedly involved in this incident.Review of manufacturing records did not reveal any waivers, concessions, manufacturing or material abnormalities that could have contributed to this issue.It was also confirmed that all devices were sterilised.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.No further actions are required at this time.The medical documents were reviewed.The elevated crp and esr, and intraoperative findings of pus may be consistent with findings associated with infection; however, the origin of the infection is highly likely of an exogenous nature and there is no evidence that our product contributed to the infection.The elevated cobalt, necrosis, trunnionosis and pseudotumor may be consistent with findings associated with metal debris; however, the root cause of the necrosis, trunnionosis and pseudotumor cannot be confirmed, and it cannot be concluded that the reported clinical reactions were associated with a mal-performance of the implant.The patient impact beyond the pain, revision, and expected transient post-op convalescence period cannot be determined.It was also noted that use of a competitor¿s (zimmer) cup was implanted with the hemi head at the time of revision.This activity was performed contrary to the instructions for use of for bhr implants which states under its important medical information, ¿do not mix components from other manufacturers.¿ without return of the actual devices or further information we cannot further investigate or confirm the details supplied in this complaint, and our investigation remains inconclusive.If the products or additional information become available in the future, this case will be reopened.No preventative or corrective action has been initiated as a result of this investigation.
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