MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE JOINT PROSTHESIS; ENDO-MODEL SL, FEMORAL COMPONENT, CEMENTED, INTRACONDYLAR, RIGHT, SMALL, UHMWPE,

Model Number	16-2821/21
Medical Device Problem Codes	Break (1069); Material Split, Cut or Torn (4008)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	12/04/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In (b)(6) 2024, the patient developed abnormal sound in the right knee joint without obvious cause, and then he was treated in our hospital.In (b)(6) 2024, the imaging examination showed the postoperative performance of the right knee joint.There was no obvious prosthesis fracture, and the medial and lateral gaps of the right knee artificial joint were unequal.On (b)(6) 2024, the right knee artificial joint revision was performed, and the medial and lateral femoral condyle gaskets were fractured and damaged.Link small femoral condyle and small connecting shaft were replaced.The patient recovered smoothly after the operation and was discharged on (b)(6) 2024.[customer].
Event or Problem Description
In (b)(6) 2024, the patient developed abnormal sound in the right knee joint without obvious cause, and then he was treated in our hospital.In (b)(6) 2024, the imaging examination showed the postoperative performance of the right knee joint.There was no obvious prosthesis fracture, and the medial and lateral gaps of the right knee artificial joint were unequal.On (b)(6) 2024, the right knee artificial joint revision was performed, and the medial and lateral femoral condyle gaskets were fractured and damaged.Link small femoral condyle and small connecting shaft were replaced.The patient recovered smoothly after the operation and was discharged on (b)(6) 2024.[customer].
Additional Manufacturer Narrative
The review of the device history record showed no deviations.The product complies with the specifications valid at the time of manufacture.This is the final supplemental report, the complaint is closed.

• Brand Name: ENDO-MODEL SL KNEE JOINT PROSTHESIS
• Common Device Name: ENDO-MODEL SL, FEMORAL COMPONENT, CEMENTED, INTRACONDYLAR, RIGHT, SMALL, UHMWPE,
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 21823491
• Report Number: 3004371426-2025-00018
• Device Sequence Number: 15766365
• Product Code: KRO
• UDI-Device Identifier: 04026575392230
• UDI-Public: 04026575392230
• Combination Product (Y/N): N
• Initial Reporter Country: CH
• PMA/510(K) Number: K151008
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2024
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/14/2025

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?: No
• Operator of Device: Health Professional
• Device Expiration Date: 08/31/2023
• Device Model Number: 16-2821/21
• Device Catalogue Number: 16-2821/21
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/14/2025
• Supplement Date Received by Manufacturer: 03/14/2025
• Initial Report FDA Received Date: 04/11/2025
• Supplement Report FDA Received Date: 02/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 08/01/2018
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 19 YR
• Patient Sex: Male