It was reported that there was an issue with as vega ps tibial.According to the customer description it was reported that as a result of having the product implanted, the patient has experienced as vega knee loosening which resulted in a revision surgery.The primary surgery occurred on (b)(6) 2013, and the revision surgery occurred on (b)(6) 2019.All available information has been provided at this time, if additional information becomes available the complaint will be updated accordingly.Involved components: as vega ps femoral comp.Cemented f4n r - nx029z - unknown, patella 3-pegs p2 - nx042 - unknown, vega ps gliding surface t1/1+ 14mm - nx112 - vega ps gliding surface t1/1+ 14mm, plug f/tibial plateau - nn260p - unknown.Additional information was not provided nor available / was not available.Additional patient information is not available.The adverse event / malfunction is filed under aag reference (b)(4).
|
Investigation results: the affected device was not available for investigation.Therefore an investigation of the device was not possible.Due to the fact that no lot number was provided, a review of the device history records for the complained device is not possible.The determination of a definite root cause is due to the non-availability of important information and the device itself not possible.The conclusion from the root cause analysis is that a systematic device deviation is unlikely since the received complaints are limited to certain health care institutions and their applicants.The participation of the applicants in this deviation scenario cannot be excluded by today.Based on the root cause analysis result no corrective actions have been carried out.As a preventive action we were in contact with the affected health care institutions and applicants in order to reduce the probability of recurrence.The complaints were submitted to aesculap ag as a summary report.In order to examine further actions, all cases from the summary report are processed as vigilance suspicion cases and are continuously monitored.
|