The reported event could be confirmed, since the documentation provided to the medical expert, confirmed the patient pain.This conclusion was verified by a medical expert upon review of the patient's case documentation.Medical expertise: "it is not medical grade, but they are sufficient to reliably assess areas of periprosthetic radiolucencies that are compatible with the (confirmed) diagnosis of periprosthetic joint infection." [¿] "the pain is most likely related to the periprosthetic joint infection (pji).Common presentations of c.Acnes pji include unexplained pain, stiffness, and component loosening after an initially good outcome and the usual period for acute postoperative infection has passed.C.Acnes may not present symptoms for two years or more post operatively.Good recovery of function and pain control followed by increase in pain and stiffness suggest c.Acnes, particularly in males." [¿] "the implant is well positioned.The pain is related to the periprosthetic joint infection " [¿] "the pathology report confirms the inflammatory response in the glenohumeral joint and fits well with the infection that was diagnosed on the basis of the positive cultures." also, the presence of the acromial osteophyte could not be confirmed by the medical expert: "the quality and the number of ct scan slice are too limited to see the osteophyte." the root cause about the pain is due to the infection.Furthermore, based on the clinical opinion on the potential risk of infection caused by sterile packed stryker implants and instruments, ¿any kind of surgery bears the risk of infection.In trauma and orthopedic surgery with external or internal fixation implants or endoprostheses the infection risk varies between 0.5 % and 5 %, exceptionally up to 10 % and beyond, mainly depending on the respective surgical procedure and the typical patient population." a review of the device history for the reported lot did not indicate any abnormalities.No corrective actions are required at this time.A review of the labeling did not indicate any abnormalities.No indications of material, manufacturing or design related problems were found during the investigation.If the device is returned or if any additional information is provided, the investigation will be reassessed.
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