MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG GEMINI SL; TOTAL KNEE SYSTEM, ARTICULATING SURFACE, FIXED BEARING PS, RIGHT, SZ. MEDIUM,

Model Number	318-253/10
Medical Device Problem Code	Fracture (1260)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	05/23/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
After the implantation done in 2021, in (b)(6) 2024, the patience complained of pain and after the x-ray check it was found the tibial screw of insert is broken.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.
Event or Problem Description
After the implantation done in 2021, in (b)(6) 2024, the patience complained of pain and after the x-ray check it was found the tibial screw of insert is broken.[customer].

• Brand Name: GEMINI SL
• Common Device Name: TOTAL KNEE SYSTEM, ARTICULATING SURFACE, FIXED BEARING PS, RIGHT, SZ. MEDIUM,
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: andreas brandt ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 19718492
• Report Number: 3004371426-2024-00051
• Device Sequence Number: 8130383
• Product Code: JWH
• UDI-Device Identifier: 04026575394708
• UDI-Public: 04026575394708
• 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: 2021
• 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): 06/18/2024

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?: Yes
• Operator of Device: Health Professional
• Device Expiration Date: 03/31/2025
• Device Model Number: 318-253/10
• Device Catalogue Number: 318-253/10
• Device Lot Number: 2002007
• 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: 06/18/2024
• Supplement Date Received by Manufacturer: 06/18/2024
• Initial Report FDA Received Date: 07/11/2024
• Supplement Report FDA Received Date: 02/06/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 04/01/2020
• 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: 72 YR
• Patient Sex: Unknown