H3, h6: the device was not available for evaluation.The pictures provided were reviewed and could not confirm the stated failure mode.The clinical/medical investigation concluded that, the root cause of the first revision (2-stage) was due to a deep infection with s.Epidermidis and related symptoms; however, the mechanism of contamination which led to the deep infection could not be definitively concluded.The post-op ¿bleeding anemia¿ and subsequent transfusion was most likely due to the surgical procedure itself and does not reflect a component mal-performance.The assessed patient impact was the pain, swelling, infection, synovitis, aspirate, 2-stage revision, antibiotic therapy, blood loss anemia, and prbc transfusion.Further patient impact could not be assessed.No further medical assessment can be rendered at this time.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 complaint history for the part number over the past 12 months and for the batch number based on historical data of the device did not reveal similar events for the listed device.A review of the risk management file revealed this failure mode was previously identified.A review of the ifu document for knee systems provides complete guidelines of indications, contraindications, warnings and precautions and possible adverse effects that may occur preoperative, during surgery or post operative.The anticipated risk level is still adequate.A review of the sterilization records revealed the batch was sterilized within normal parameters.A historical review concluded that there are no prior actions related to this product and event.At this time, we have no reason to suspect that the product failed to meet any product specifications at the time of manufacture.Some potential probable causes for this event could include but not limited to surgical procedure, surgical complication or patient medical history.The contribution of the device to the reported event could not be corroborated.Based on this investigation, the need for corrective action is not indicated.Without the return of the actual product involved, 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.
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