It was reported that after a left tka performed on (b)(6) 2012 due to osteoarthritis, the patient experienced a aseptic loosening of the tibial component.This was addressed via revision surgery on (b)(6) 2019 were all components where exchange to competitor´s implants.This information was provided by the national joint registry of (b)(6), as part of a retrospective data collection of patients who underwent a revision surgery of journey uni prothesis.As such, no further information will be available.
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H3, h6: given the nature of the alleged incident, the device, could not be returned for evaluation and the reported event could not be confirmed.The clinical/medical investigation concluded that, per complaint details, a left revision was performed approximately 7 years post uka due to aseptic loosening of the tibial component.As of the date of this medical investigation, the requested clinical documentation has not been received as the information was provided by the national joint registry of the united kingdom as part of a retrospective data collection, and reportedly, no further information will be available.Without the requested medical documentation, possible clinical factors which could have contributed to the reported event could not be definitively concluded.The patient impact beyond that which was reported could not be determined.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 abnormal motion over time, bone degeneration, fit/sizing issue, lack of ingrowth, osteolysis and/or traumatic injury.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.Internal complaint reference number: (b)(4).
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