MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG MEGASYSTEM-C; FEMORAL COMPONENTS,INTRACONDYLARLINK MEGASYSTEM-C,MEDIUM, LEFT,

Model Number	15-8521/32
Medical Device Problem Codes	Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)
Health Effect - Clinical Code	Failure of Implant (1924)
Date of Event	09/04/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Deconnection of unclear cause of the cementless stem from the femoral condyle.
Event or Problem Description
Disconnection of unclear cause of the cementless stem from the femoral condyle.[customer].
Additional Manufacturer Narrative
This is the final supplemental report.The complaint is closed.

• Brand Name: MEGASYSTEM-C
• Common Device Name: FEMORAL COMPONENTS,INTRACONDYLARLINK MEGASYSTEM-C,MEDIUM, LEFT,
• 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: 18309047
• Report Number: 3004371426-2023-00108
• Device Sequence Number: 20486943
• Product Code: KRO
• UDI-Device Identifier: 04026575386499
• UDI-Public: 04026575386499
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2023
• Device Explanted Year: 2023
• 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): 09/22/2023

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
• Device Model Number: 15-8521/32
• Device Catalogue Number: 15-8521/32
• 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: 11/22/2023
• Supplement Date Received by Manufacturer: 11/22/2023
• Initial Report FDA Received Date: 12/12/2023
• Supplement Report FDA Received Date: 03/04/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 07/01/2023
• 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: 65 YR
• Patient Sex: Male