MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENTS; FEMORAL COMPONENTS, CONDYLAR REPLACEMENT LINK MEGASYSTEM-C, SMALL, RIGHT

Model Number	15-8521/06
Medical Device Problem Code	Detachment of Device or Device Component (2907)
Health Effect - Clinical Code	Unspecified Infection (1930)
Date of Event	01/05/2023
Type of Reportable Event	Serious Injury
Event or Problem Description
Due to excessive swelling , (b)(6) undertook a revision surgery on the patient on (b)(6) 2023 to debride/wash out the joint and replace the plateau, and discovered condyle cap from the femoral component condylar replacement loose in the joint space, sitting in front of the knee.
Event or Problem Description
Due to excessive swelling, dr.(b)(6) undertook a revision surgery on the patient on (b)(6) 2023 to debride/wash out the joint and replace the plateau, and discovered condyle cap from the femoral component condylar replacement loose in the joint space, sitting in front of the knee.
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.

• Brand Name: FEMORAL COMPONENTS
• Common Device Name: FEMORAL COMPONENTS, CONDYLAR REPLACEMENT LINK MEGASYSTEM-C, SMALL, RIGHT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: lisa effe ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16172828
• Report Number: 3004371426-2023-00003
• Device Sequence Number: 2429320
• Product Code: KRO
• UDI-Device Identifier: 04026575383191
• UDI-Public: 04026575383191
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K143179
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Device Implanted Year: 2022
• Device Explanted Year: 2023
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Distributor
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 01/05/2023

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: 04/30/2023
• Device Model Number: 15-8521/06
• Device Catalogue Number: 15-8521/06
• 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: 01/05/2023
• Supplement Date Received by Manufacturer: 01/05/2023
• Initial Report FDA Received Date: 01/16/2023
• Supplement Report FDA Received Date: 05/16/2023
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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: 68 YR
• Patient Sex: Male