Corrected data: device manufacture date.An event regarding component loosening involving a avon patellar component was reported.The event was not confirmed.Method & results: the device was not returned for evaluation no bilateral primary patellofemoral operative reports, no bilateral first revision operative reports, and no documentation of the implanted components and whether the avon patellar components were retained at the time of the bilateral revision to total knee arthroplasties are available.There are no readable serial x-rays or no examination of the explanted components available.There is no confirmation of mechanical loosening of the patellar components or if they were articulating properly with the femoral components of the total knee arthroplasties.There is no evidence that this patient¿s clinical problems were the result of factors of faulty component design, manufacturing or materials.The device was manufactured and accepted into final stock with no reported discrepancies.There have been no other events for the lot referenced.Conclusions: the exact cause of the event could not be determined because insufficient information has been received.The medical review indicates that there are no primary or revision operative reports and no documentation of the implanted components and also no indication whether the avon patellar components were retained at the time of the bilateral revision to total knee arthroplasties.There are no readable serial x-rays or no examination of the explanted components available.The medical review further indicates that there is no confirmation of mechanical loosening of the patellar components or if they were articulating properly with the femoral components of the total knee arthroplasties.There is no evidence that this patient¿s clinical problems were the result of factors of faulty component design, manufacturing or materials.No further investigation for this event is possible at this time as no devices and insufficient information was received by stryker orthopaedics.If devices and / or additional information become available, this investigation will be reopened.
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