MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO.KG GEMINI SL; FEMORAL COMPONENT

Model Number	318-103/03
Medical Device Problem Codes	Degraded (1153); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Codes	Failure of Implant (1924); Insufficient Information (4580)
Date of Event	12/14/2022
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
Aseptic mobilization left total knee replacement.
Event or Problem Description
Aseptic mobilization left total knee replacement.
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.An "aseptic mobilization" after a standing time of 12 years had been reported.Aseptic loosening is a known complication documented in the ifu (instruction for use).
Event or Problem Description
Aseptic mobilization left total knee replacement.
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 report is the final supplemental report, the complaint ist closed.

• Brand Name: GEMINI SL
• Common Device Name: FEMORAL COMPONENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO.KG; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, hamburg 22339 ; GM 22339
• MDR Report Key: 16277024
• Report Number: 3004371426-2023-00005
• Device Sequence Number: 6474927
• Product Code: JWH
• UDI-Device Identifier: 04026575311392
• UDI-Public: 04026575311392
• 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: 2010
• Device Explanted Year: 2022
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 01/11/2023

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: 08/31/2014
• Device Model Number: 318-103/03
• Device Catalogue Number: 318-103/03
• 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: 01/11/2023
• Supplement Date Received by Manufacturer: 01/11/2023; 01/11/2023
• Initial Report FDA Received Date: 02/01/2023
• Supplement Report FDA Received Date: 08/04/2023; 11/07/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• 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: 80 YR
• Patient Sex: Unknown