MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG ENDO-MODEL; ENDO-MODEL, REPLACEMENT SET, RIGHT/LEFT, M, UHMWPE, COCRMO, ROTATING HINGE

Model Number	15-0027/12
Medical Device Problem Codes	Off-Label Use (1494); Unstable (1667); Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Joint Laxity (4526)
Date of Event	06/06/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
In (b)(6) 2024 a feeling of knee failure was reported.X-ray diagnosis shows unstable knee.[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.
Event or Problem Description
In (b)(6) 2024, a feeling of knee failure was reported.X-ray diagnosis shows unstable knee.[customer].

• Brand Name: ENDO-MODEL
• Common Device Name: ENDO-MODEL, REPLACEMENT SET, RIGHT/LEFT, M, UHMWPE, COCRMO, ROTATING HINGE
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg 22339 ; GM 22339
• Manufacturer Contact: annerike-tizia hucklenbroch ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 19882304
• Report Number: 3004371426-2024-00047
• Device Sequence Number: 17180719
• Product Code: KRO
• UDI-Device Identifier: 04026575431960
• UDI-Public: 04026575431960
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• 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): 06/20/2024

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: 01/31/2026
• Device Model Number: 15-0027/12
• Device Catalogue Number: 15-0027/12
• Device Lot Number: 2108045
• 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: 06/20/2024
• Supplement Date Received by Manufacturer: 06/20/2024
• Initial Report FDA Received Date: 08/01/2024
• Supplement Report FDA Received Date: 07/11/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/01/2021
• 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: 50 YR
• Patient Sex: Male