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

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 , (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 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.

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
• Type of Device: 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
• MDR Text Key: 307465538
• Report Number: 3004371426-2023-00003
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575383191
• UDI-Public: 04026575383191
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/16/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/05/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 04/01/2018
• 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: 68 YR
• Patient Sex: Male