MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG FEMORAL COMPONENT CONDYLAR REPLACEMENT MEGASYSTEM-C; UNCOATED KNEE FEMUR PROSTHESIS

Catalog Number 15-8521/10

Device Problem Detachment of Device or Device Component (2907)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 04/27/2021

Event Type  malfunction  

Event Description

It was reported that while revising an entire femoral component during surgery the same day, it was discovered that a plastic piece had come off the femoral component.

Event Description

It was reported that while revising an entire femoral component during surgery the same day, it was discovered that a plastic piece had come off the femoral component.

• Brand Name: FEMORAL COMPONENT CONDYLAR REPLACEMENT MEGASYSTEM-C
• Type of Device: UNCOATED KNEE FEMUR PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 12202460
• MDR Text Key: 264938789
• Report Number: 3004371426-2021-00022
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 07/02/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 15-8521/10
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 07/02/2021
• Initial Date FDA Received: 07/21/2021
• Supplement Dates Manufacturer Received: 07/02/2021
• Supplement Dates FDA Received: 10/25/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Age: 49 YR