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

Model Number 318-103/03

Device Problems Degraded (1153); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 12/14/2022

Event Type  Injury  

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 Description

Aseptic mobilization left total knee replacement.

Event Description

Aseptic mobilization left total knee replacement.

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 Description

Aseptic mobilization left total knee replacement.

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
• Type of Device: 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
• MDR Text Key: 308534874
• Report Number: 3004371426-2023-00005
• Device Sequence Number: 1
• Product Code: JWH
• UDI-Device Identifier: 04026575311392
• UDI-Public: 04026575311392
• Combination Product (y/n): N
• Reporter Country Code: IT
• PMA/PMN Number: K182872
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup,Followup
• Report Date: 01/11/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: 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
• Date Manufacturer Received: 01/11/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 08/01/2009
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR