MAUDE Adverse Event Report: Waldemar Link GmbH & Co. KG Link Endo-Model; Rotation Knee JointP.,pat. flange,anti-lux.,medium, left

Model Number	15-8024/12
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	08/03/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
Fracture of screw."[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.

• Brand Name: Link Endo-Model
• Common Device Name: Rotation Knee JointP.,pat. flange,anti-lux.,medium, left
• 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: 50429170
• Report Number: 3004371426-2026-00069
• Device Sequence Number: 13131410
• Product Code: KRO
• UDI-Device Identifier: 04026575048052
• UDI-Public: 04026575048052
• 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: 2026
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Type of Report: Initial
• Report Date (Section B): 08/13/2026

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?: No
• Operator of Device: Health Professional
• Device Model Number: 15-8024/12
• Device Catalogue Number: 15-8024/12
• 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: 08/13/2026
• Initial Report FDA Received Date: 08/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 03/01/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 89 YR
• Patient Sex: Female