MAUDE Adverse Event Report: AESCULAP AG AS ENDURO FEMORAL COMPONENT CEMENTED F2R; KNEE ENDOPROSTHESES

Model Number NB018Z

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 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.66017772, 40g refobacin palacos lot 94274757, ref.66017747.A revision surgery was necessary.The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: 9610612-2020-00374 (400479789 + nb012z), 9610612-2020-00375 (400479790 + nr292z), 9610612-2020-00376 (400479791 + nr192z), 9610612-2020-00377 (400479792 + nr400z), 9610612-2020-00378 (400479793 + nr880z).

Event Description

The adverse event is filed under aag reference (b)(4).Associated medwatch-reports: (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).

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.

• Brand Name: AS ENDURO FEMORAL COMPONENT CEMENTED F2R
• Type of Device: KNEE ENDOPROSTHESES
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 10344743
• MDR Text Key: 203525276
• Report Number: 9610612-2020-00373
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K101815
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative
• Type of Report: Initial,Followup
• Report Date: 08/26/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/30/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NB018Z
• Device Catalogue Number: NB018Z
• Device Lot Number: 52570629
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 07/29/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR