Model Number NR292Z |
Device Problem
Patient Device Interaction Problem (4001)
|
Patient Problem
Patient Problem/Medical Problem (2688)
|
Event Date 07/07/2020 |
Event Type
Injury
|
Manufacturer Narrative
|
Manufacturing site evaluation: investigation on-going.Additional information / investigation results will be provided in a supplemental report.
|
|
Event Description
|
It was reported that there was an issue with a as enduro prothesis.According to the complaint description a revision was necessary due to a faulty patella 6 month postoperative.Patient had had a defective paella primarily after valgus situation.Patella was very thin (5mm).During the procedure we noticed that it was locally black around the patella tissue.Black discoloration was also visible in the tibial interface bone.The surgeon also sent a tissue sample to the laboratory.The knee was not loosened and also inconspicuous from the coupling mechanism.No explant received, only tissue sample.60g refobacin palacos lot 92690028, ref.(b)(4).40g refobacin palacos lot 94274757, ref.(b)(4).A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00373 (400478165 + nb018z).9610612-2020-00374 (400479789 + nb012z).9610612-2020-00376 (400479791 + nr192z).9610612-2020-00377 (400479792 + nr400z).9610612-2020-00378 (400479793 + nr880z).
|
|
Manufacturer Narrative
|
Investigation results after data analysis: a visual investigation cannot be performed, because no product at hand, therefore an investigation at the device is not possible.The device history records have been checked for all available lot numbers and found to be according to the specification, valid at the time of production.No further complaints registered against any of the above mentioned lot numbers.Based on the available information it is not possible to determine a root cause for the failure.
|
|
Event Description
|
The adverse event is filed under aag reference 100025882.Associated medwatch-reports: 9610612-2020-00373 (b)(4), 9610612-2020-00374 (b)(4), 9610612-2020-00375 (b)(4), 9610612-2020-00376 (b)(4), 9610612-2020-00377 (b)(4), 9610612-2020-00378 (b)(4).
|
|
Search Alerts/Recalls
|