MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL NON-ROTATIONG HINGE KNEE PROSTHESIS; CONNECTION COMPONENT HINGE VERSION, MEDIUM

Device Problems Fracture (1260); Detachment of Device or Device Component (2907)

Patient Problems Fall (1848); Failure of Implant (1924); Joint Laxity (4526)

Event Date 03/02/2023

Event Type  Injury  

Event Description

Knee prosthesis revision in case of broken shaft of the prosthesis.

Manufacturer Narrative

The affected article is not approved in the usa.

Event Description

Knee prosthesis revision due to damaged connection component of the prosthesis.

• Brand Name: ENDO-MODEL SL NON-ROTATIONG HINGE KNEE PROSTHESIS
• Type of Device: CONNECTION COMPONENT HINGE VERSION, MEDIUM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 16599212
• MDR Text Key: 311863823
• Report Number: 3004371426-2023-00016
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 03/03/2023

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
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/03/2023
• Initial Date FDA Received: 03/23/2023
• Supplement Dates Manufacturer Received: 03/03/2023
• Supplement Dates FDA Received: 10/20/2023
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 02/01/2015
• 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: 69 YR
• Patient Sex: Male