MAUDE Adverse Event Report: AESCULAP AG AS; PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL

Model Number	NN261Z
Medical Device Problem Code	Patient-Device Incompatibility (2682)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	06/21/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
An outside law firm reported that a patient experienced complications with an aesculap knee implant.Reportedly the femoral component was "grossly loose" and "removed by hand".The tibial component was also "grossly loose" and "lifted out of the cement mantle" the cement mantle remained adhered to the bones and had to be extracted during the revision surgery.Additional information has been requested but not yet provided.This report is filed under ais reference (b)(4).

• Brand Name: AS
• Common Device Name: PROSTHESIS, KNEE, PATELLOFEMOROTIBIAL, SEMI-CONSTRAINED, CEMENTED, POLYMER/METAL
• Manufacturer (Section D): AESCULAP AG; po box 40; tuttlingen, 78501 ; GM 78501
• MDR Report Key: 25432405
• Report Number: 3005673311-2026-00100
• Device Sequence Number: 21410121
• Product Code: JWH
• UDI-Device Identifier: 04046963124502
• UDI-Public: (01)04046963124502(11)180207(17)280131(10)52405534
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2018
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Importer
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/02/2026
• Report Date (Section F): 06/08/2026

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
• Operator of Device: Health Professional
• Device Model Number: NN261Z
• Device Catalogue Number: NN261Z
• Device Lot Number: 52405534
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Distributor Facility Aware Date: 05/14/2026
• Device Age: 64 MO
• Event Location: Hospital
• Date Report to Manufacturer: 05/14/2026
• Type of Report(Section G): Follow-Up
• Initial Date Received by Manufacturer: Not provided
• Supplement Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 06/08/2026
• Supplement Report FDA Received Date: 07/02/2026
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 70 YR
• Patient Sex: Unknown
• Patient Weight: 104 KG
• Date Report Sent to FDA: 06/08/2026