MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL; ENDO-MODEL, PROXIMAL TIBIAL SPACER, CEMENTED, UHMWPE, 3 EA., M, H= 30MM, FULL

Model Number	15-2517/29
Medical Device Problem Codes	Unstable (1667); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Pain (1994)
Date of Event	12/03/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Based on a review of patient staging studies on (b)(6) 2024, the physician noted uptake around the left knee and suspects that revision of the tibial components is needed, potentially related to the tibial uhmwpe augment.Revision has not occurred.The patient will seek another opinion.[(b)(6)].
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.
Event or Problem Description
Based on a review of patient staging studies on (b)(6) 2024, the physician noted uptake around the left knee and suspects that revision of the tibial components is needed, potentially related to the tibial uhmwpe augment.Revision has not occurred.The patient will seek another opinion.[customer] update (b)(6) 2025: this patient has decided to pursue other options and no longer wants to have surgery.[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
• Common Device Name: ENDO-MODEL, PROXIMAL TIBIAL SPACER, CEMENTED, UHMWPE, 3 EA., M, H= 30MM, FULL
• 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: 22584668
• Report Number: 3004371426-2025-00035
• Device Sequence Number: 11887702
• Product Code: KRO
• UDI-Device Identifier: 04026575204229
• UDI-Public: 04026575204229
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 06/24/2025

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: 05/31/2026
• Device Model Number: 15-2517/29
• Device Catalogue Number: 15-2517/29
• Device Lot Number: 2121185
• 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: 06/24/2025
• Supplement Date Received by Manufacturer: 06/24/2025
• Initial Report FDA Received Date: 07/24/2025
• Supplement Report FDA Received Date: 11/18/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 06/01/2021
• 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: 79 YR
• Patient Sex: Male