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

Model Number 16-2855/22

Device Problems Detachment of Device or Device Component (2907); Material Deformation (2976)

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

Event Date 06/13/2018

Event Type  Injury  

Manufacturer Narrative

The investigation is in progress.

Event Description

It was reported that it looks like the taper between the femur and the stem failed and subsequently caused the screw collets to deform and break off.

Manufacturer Narrative

The review of the device history records showed no deviations.All product features corresponded with the valid specifications of the waldemar link gmbh & co.Kg at the time period, when the item was produced.

Event Description

It was reported that it looks like the taper between the femur and the stem failed and subsequently caused the screw collets to deform and break off.

• Brand Name: DISTAL FEMORAL REPLACEMENT COMPONENT MODULAR - ROTATIONAL KNEE SL
• Type of Device: KNEE FEMUR PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 7669478
• MDR Text Key: 113405929
• Report Number: 3004371426-2018-00004
• 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: 06/14/2018

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 02/28/2021
• Device Model Number: 16-2855/22
• Device Catalogue Number: 16-2855/22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/18/2018
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/14/2018
• Initial Date FDA Received: 07/09/2018
• Supplement Dates Manufacturer Received: 06/14/2018
• Supplement Dates FDA Received: 02/26/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 80 YR