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

Catalog Number 16-2823/22

Device Problems Detachment of Device or Device Component (2907); Loosening of Implant Not Related to Bone-Ingrowth (4002)

Patient Problem Failure of Implant (1924)

Event Date 01/19/2021

Event Type  Injury  

Event Description

It was reported that a revision surgery was performed due to loosening and disconnection of the fermoral component and the stem.

Event Description

It was reported that a revision surgery was performed due to loosening and disconnection of the fermoral component and the stem.

• Brand Name: ENDO-MODEL SL FEMORAL COMPONENT INTRACONDYLAR
• Type of Device: UNCOATED KNEE FEMUR PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 11789364
• MDR Text Key: 249428508
• Report Number: 3004371426-2021-00013
• 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: foreign,health professional
• Type of Report: Initial,Followup
• Report Date: 04/19/2021

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: 09/30/2023
• Device Catalogue Number: 16-2823/22
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/19/2021
• Initial Date FDA Received: 05/07/2021
• Supplement Dates Manufacturer Received: 04/19/2021
• Supplement Dates FDA Received: 08/12/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Weight: 128