MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG DISTAL FEMORALREPLACEMENT COMP. F.LINK® KNEE-SYSTEM

Device Problem Device Dislodged or Dislocated (2923)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

Based on the x-rays provided, it appears that the modular stem has dissociated from the femoral components.

• Brand Name: DISTAL FEMORALREPLACEMENT COMP. F.LINK® KNEE-SYSTEM
• Type of Device: DISTAL FEMORALREPLACEMENT COMP. F.LINK® KNEE-SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8446128
• MDR Text Key: 139672412
• Report Number: 3006721341-2019-00008
• 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
• Type of Report: Initial
• Report Date: 03/04/2019,02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/22/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No

Device Operator

• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/25/2019
• Event Location: No Information
• Date Report to Manufacturer: 03/04/2019
• Was Device Evaluated by Manufacturer?: No Answer Provided
• Is the Device Single Use?: No Answer Provided
• Is This a Reprocessed and Reused Single-Use Device?: No

Type of Device Usage

Patient Treatment Data

Date Received: 03/22/2019 Patient Sequence Number: 1