MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG GEMINI SL TOTAL KNEE SYSTEM; TIBIAL COMPONENT, FIXED BEARING, SMS, LINK POREX, CEMENTED, RIGHT, SZ. X-LARGE,

Model Number	318-328/05
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	11/24/2025
Type of Reportable Event	Serious Injury
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
Screw breakage between inlay and tibial component [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
Screw breakage between inlay and tibial component [customer].

• Brand Name: GEMINI SL TOTAL KNEE SYSTEM
• Common Device Name: TIBIAL COMPONENT, FIXED BEARING, SMS, LINK POREX, CEMENTED, RIGHT, SZ. X-LARGE,
• 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: 23813656
• Report Number: 3004371426-2025-00063
• Device Sequence Number: 15943492
• Product Code: JWH
• UDI-Device Identifier: 04026575412204
• UDI-Public: 04026575412204
• Combination Product (Y/N): N
• Initial Reporter Country: IT
• PMA/510(K) Number: K182872
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2025
• 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): 12/01/2025

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: 06/30/2023
• Device Model Number: 318-328/05
• Device Catalogue Number: 318-328/05
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/01/2025
• Supplement Date Received by Manufacturer: 12/01/2025
• Initial Report FDA Received Date: 12/16/2025
• Supplement Report FDA Received Date: 03/06/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 06/01/2018
• 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 Sex: Unknown