MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL, FEMORAL COMPONENT LEFT, MEDIUM (3); UNCOATED KNEE FEMUR PROSTHESIS

Catalog Number 16-2823/22

Device Problems Fracture (1260); Material Fragmentation (1261); Material Separation (1562); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problems Bone Fracture(s) (1870); Failure of Implant (1924); Osteolysis (2377)

Event Date 02/11/2020

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to instability.

Event Description

It was reported that a revision surgery was performed due to instabilitity.

• Brand Name: ENDO-MODEL SL, FEMORAL COMPONENT LEFT, MEDIUM (3)
• Type of Device: UNCOATED KNEE FEMUR PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 9909204
• MDR Text Key: 188265195
• Report Number: 3004371426-2020-00005
• 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
• Report Date: 03/11/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/01/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 03/31/2016
• Device Catalogue Number: 16-2823/22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/26/2020
• Date Manufacturer Received: 03/11/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 102