MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG DISTAL FEMORAL REPLACEMENT COMPONENT MODULAR - ROTATIONAL KNEE SL; UNCOATED KNEE FEMUR PROSTHESIS

Device Problems Detachment of Device or Device Component (2907); Device Dislodged or Dislocated (2923)

Patient Problems Failure of Implant (1924); No Known Impact Or Consequence To Patient (2692)

Event Type  Injury  

Event Description

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

Event Description

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

• Brand Name: DISTAL FEMORAL REPLACEMENT COMPONENT MODULAR - ROTATIONAL KNEE SL
• Type of Device: UNCOATED KNEE FEMUR PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8448226
• MDR Text Key: 139706314
• Report Number: 3004371426-2019-00116
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor
• Type of Report: Initial,Followup
• Report Date: 02/25/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/25/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 02/25/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention