MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG GEMINI SL; TOTAL KNEE SYSTEM, ARTICULATING SURFACE, FIXED BEARING PS, LEFT, SZ. MEDIUM, L3

Model Number	318-263/10
Medical Device Problem Codes	Fracture (1260); Material Deformation (2976)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	06/20/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
Mobilizzazione protesi asettica ginocchio sx a causa di rottura vite di bloccaggio dell'inserto in polietilene.[customer] mobilization of aseptic left knee prosthesis due to breakage of polyethylene insert locking screw.[translation via deepl] [customer].
Event or Problem Description
Mobilizzazione protesi asettica ginocchio sx a causa.Di rottura vite di bloccaggio dell'inserto in polietilene.[customer].Mobilization of aseptic left knee prosthesis due to breakage of polyethylene insert locking screw.[translation via deepl].[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: GEMINI SL
• Common Device Name: TOTAL KNEE SYSTEM, ARTICULATING SURFACE, FIXED BEARING PS, LEFT, SZ. MEDIUM, L3
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 20167859
• Report Number: 3004371426-2024-00067
• Device Sequence Number: 8032309
• Product Code: JWH
• UDI-Device Identifier: 04026575394753
• UDI-Public: 04026575394753
• 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: 2020
• 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): 08/13/2024

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
• Device Expiration Date: 07/31/2024
• Device Model Number: 318-263/10
• Device Catalogue Number: 318-263/10
• Device Lot Number: 1924079
• 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: 08/13/2024
• Supplement Date Received by Manufacturer: 08/13/2024
• Initial Report FDA Received Date: 09/09/2024
• Supplement Report FDA Received Date: 08/20/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/01/2019
• 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