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

Catalog Number 16-2825/22

Device Problems Material Fragmentation (1261); Failure to Osseointegrate (1863); Detachment of Device or Device Component (2907)

Patient Problems Failure of Implant (1924); Insufficient Information (4580)

Event Date 10/28/2021

Event Type  Injury  

Event Description

It was reported that a revision surgery is scheduled to address a disconnection of the femoral component.

Event Description

It was reported that a revision surgery is scheduled to address a disconnection of the femoral component.

• 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
• Manufacturer Contact: rebekka winterhoff ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 12785173
• MDR Text Key: 284885258
• Report Number: 3004371426-2021-00028
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K151008
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 10/29/2021

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 Catalogue Number: 16-2825/22
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/29/2021
• Initial Date FDA Received: 11/10/2021
• Supplement Dates Manufacturer Received: 10/29/2021
• Supplement Dates FDA Received: 04/27/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 08/01/2020
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR
• Patient Sex: Male
• Patient Weight: 113 KG