MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL FEMORAL COMPONENT INTRACONDYLAR MODULAR; UNCOATED KNEE FEMUR PROSTHESIS

Model Number 16-2823/22

Device Problems Crack (1135); Fracture (1260); Insufficient Information (3190); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 07/02/2019

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to loosening of the femoral component and failure of the taper junction.

Event Description

It was reported that a revision surgery was performed due to loosening of the femoral component and failure of the taper junction.

Event Description

It was reported that a revision surgery was performed due to loosening of the femoral component and failure of the taper junction.

• Brand Name: ENDO-MODEL SL FEMORAL COMPONENT INTRACONDYLAR MODULAR
• Type of Device: UNCOATED KNEE FEMUR PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 8978591
• MDR Text Key: 157783386
• Report Number: 3004371426-2019-00128
• 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: company representative,foreig
• Type of Report: Initial,Followup,Followup
• Report Date: 08/30/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/10/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/30/2018
• Device Model Number: 16-2823/22
• Device Catalogue Number: 16-2823/22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/17/2020
• Date Manufacturer Received: 08/05/2019
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 72 YR