The reported event (infection) could be confirmed.The device was not returned but evidences were provided based on the reported data in the clinical study.Since data and x-rays were provided, the opinion of the medical expert was requested and stated as following: since there¿s no date on it is difficult to comment on it.Nevertheless the amount of humeral bone loss is significant, so is the space between the one and the lateral aspect of the proximal humerus.That is suspect for (septic) loosening.The swelling, positive culture and earlier implant loosening as reported on the ct-scan are in line with periprosthetic joint infection.In retrospect, the preoperative images show bone loss that may be attributed to infection.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.A device inspection was not possible since the affected device was not returned, and no other evidences were provided for investigation.The batch record could not be reviewed because the affected device was not returned, and the lot number was not communicated.More information as well as the affected device must be available in order to determine the exact root cause of the alleged failure.However, 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 labeling did not indicate any abnormalities.If the device is returned or if any additional information is provided, the investigation will be reassessed.
|