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

Catalog Number 15-2812/12

Device Problem Detachment of Device or Device Component (2907)

Patient Problem Failure of Implant (1924)

Event Date 07/01/2021

Event Type  Injury  

Event Description

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

Event Description

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

• Brand Name: ENDO-MODEL M ROTATION KNEE FEMORAL COMPONENT
• 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: 12179079
• MDR Text Key: 261895830
• Report Number: 3004371426-2021-00019
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• PMA/PMN Number: K143179
• 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: 07/07/2021

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: 07/31/2022
• Device Catalogue Number: 15-2812/12
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/16/2021
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/07/2021
• Initial Date FDA Received: 07/16/2021
• Supplement Dates Manufacturer Received: 07/07/2021
• Supplement Dates FDA Received: 12/17/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/01/2017
• 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 Sex: Female
• Patient Weight: 120 KG