MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO MODEL; ENDO-MODEL® - M, ROTATIONAL KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS LEFT, SMALL,

Model Number	15-3816/12
Medical Device Problem Code	Separation Failure (2547)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/25/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device history record has been inspected and reviewed.This is the final supplemental report, the complaint is closed.
Event or Problem Description
Reported that in a procedure, the blind screw on the component could not be backed out.An additional component was opened and the tibial component from that implant was instead used in the procedure.Only a delay of approximately 5 minutes was reported.Note: the representative did ensure the surgeon understood that the alternate cementing technique should be used per the field notice associated with the blind screw removal issues, however the surgeon did not agree with this approach and preferred to open a new implant.[customer].

• Brand Name: ENDO MODEL
• Common Device Name: ENDO-MODEL® - M, ROTATIONAL KNEE PROSTHESIS, KNEE-JOINT PROSTHESIS LEFT, SMALL,
• 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: 24604051
• Report Number: 3004371426-2026-00020
• Device Sequence Number: 16036743
• Product Code: KRO
• UDI-Device Identifier: 04026575034758
• UDI-Public: 04026575034758
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K152431
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 02/26/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Model Number: 15-3816/12
• Device Catalogue Number: 15-3816/12
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/16/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 11/01/2023
• 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
• Patient Age: 55 YR
• Patient Sex: Female