Manufacturing site evaluation: the device was not returned to the manufacturer for physical evaluation.Additionally, no on-site evaluation of the unit was performed and no parts were returned for failure analysis.Therefore, the investigation was not able to confirm a device issue that could be associated with the reported event.Batch history review: the device history records (dhr) were reviewed for the reported lot number; the device was found to be within specification at the time of production.All device history records (dhr) are reviewed and released according to documented procedures and a device is not released if it does not meet requirements or is nonconforming.No similar complaints were identified against the same lot number with a similar reported event.Conclusion: a definitive conclusion regarding the complaint incident cannot be reached without a physical examination of the complaint device.There is no indication of a material defect, manufacturing failure, or design error on the basis of the device history record.For further investigation, examination of the complaint device is required.
|
It was reported to aesculap inc.That a columbus rev f hc glid.Surf.T1/1+ 12mm (part # nr611m) was implanted during a left knee revision surgery performed on (b)(6) 2018.According to the complainant, post-operative bone deterioration of femur and tibia occurred.The complaint device has not been returned to the manufacturer for evaluation.An additional medical intervention was required.According to the patient , a revision surgery in the future is likely.Additional information was not provided.The malfunction is filed under aic reference (b)(4).Associated medwatch reports: (b)(4)- nr191z (2916714-2022-00055), (b)(4)- nr291z (2916714-2022-00056), (b)(4)- nr565z (2916714-2022-00057), (b)(4)- nr565z (2916714-2022-00058), (b)(4)- nr071z (2916714-2022-00060), (b)(4)- nr005z (2916714-2022-00061), (b)(4)- nr400z (2916714-2022-00062).
|