MAUDE Adverse Event Report: AESCULAP AG AS FEMUR EXTENS.STEM 6 D12X77 CEMENTED; KNEE ENDOPROSTHETICS

Model Number NR291Z

Device Problem Patient Device Interaction Problem (4001)

Patient Problem Pain (1994)

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 as femur extens.Stem 6° d12x77 cemented.The pre-operative diagnosis in 2017 was status post primary knee replacement with multi-directional instability.The patient was initially implanted with enduro components on (b)(6) 2017.Treatment included stimulan pellets with 240mg of tobramycin and 500 mg of vancomycin per mixture; and components were comented one-on-one with tobramycin.There was a failed right total knee with hinge, revision due to loosening and black wear debris seen in synovium on (b)(6) 2020.The patient had been having increased knee pain throughout the day and night; arthrofibrosis was noted.A revision surgery was necessary.The implant that was revised was the aesculap enduro femur.Tranexamic acid had been given during the procedure.All components were cemented one-on-one with tobramycin, followed by stimulan pellets and tobramycin and vancomycin mixture.Additional information was requested.The adverse event is filed under xc (b)(4).

Manufacturer Narrative

General information: the product is not available for an investigation.Consequences for the patient post-operative medical intervention was necessary: revision surgery.Investigation: no product at hand, therefore an investigation at the devices is not possible.Conclusion and root cause: based on the information available it is not possible to determine a definitive root cause for the failure at that time.Rationale: there are many potential sources regarding to implant loosening: modification/ change in the surgical technique; cement technique; patient fall; patient allergy/infection.Product safety case was created.

• Brand Name: AS FEMUR EXTENS.STEM 6 D12X77 CEMENTED
• Type of Device: KNEE ENDOPROSTHETICS
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 9958907
• MDR Text Key: 187791680
• Report Number: 9610612-2020-00102
• 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,foreig
• Type of Report: Initial,Followup
• Report Date: 06/30/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: NR291Z
• Device Catalogue Number: NR291Z
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2020
• Initial Date FDA Received: 04/14/2020
• Supplement Dates Manufacturer Received: 06/10/2020
• Supplement Dates FDA Received: 07/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention