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

Model Number 15-8521/06

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Unspecified Infection (1930)

Event Date 01/05/2023

Event Type  Injury  

Event 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.

• Brand Name: LINK MEGASYSTEM-C FEMORAL COMPONENTS
• Type of Device: FEMORAL COMPONENT MEGASYSTEM-C CONDYLAR REPLACEMENT, SMALL, RIGHT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16196467
• MDR Text Key: 307609464
• Report Number: 3006721341-2023-00001
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/05/2023,01/18/2023

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?: Yes
• Device Operator: 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
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 01/05/2023
• Event Location: Hospital
• Date Report to Manufacturer: 01/05/2023
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 01/18/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 68 YR
• Patient Sex: Male