H3, h6: the device, used in treatment, was not returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that per complaint details, a revision was scheduled due to suspected acetabular component loosening secondary to lysis.However, upon inspection, there was a cyst found under the well-fixed cup which was reportedly excised and filled with bone graft along with implantation of a new liner and head.It was communicated that medical documentation would not be provided due to lack of consent.Based on the information provided, the root cause of the revision was the cystic formation under the cup which was believed to be loosening/lysis; however, the cause of the cyst could not be concluded.The patient impact beyond the reported findings and interventions could not be determined, as no injury was reported.No further medical assessment could be rendered at this time.A review of complaint history did not reveal additional complaints for the listed batch.A review of the manufacturing records did not reveal a manufacturing abnormality that could have caused or contributed to the reported incident.A review of risk management files and the instructions for use found that the reported failure was documented appropriately.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Factors and/or some potential probable causes that could contribute to the reported event have been identified as but not limited to abnormal motion over time, bone degeneration, design of device, fit/sizing, lack of ingrowth, lifetime of device, and traumatic injury.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved or product information, our investigation could not proceed.Should the device or additional information be received, the complaint will be reopened.No further investigation is warranted for this complaint; however, we will continue to monitor for future complaints and investigate as necessary.We consider this investigation closed.
|