MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROTHESIS SYSTEM

Model Number 15-3817/12

Device Problem Material Split, Cut or Torn (4008)

Patient Problem Insufficient Information (4580)

Event Date 03/27/2023

Event Type  Injury  

Event Description

The patient underwent revision tka receiving this hinged knee device (b)(6) 2022, and underwent revision of this device on (b)(6) 2023.The bushing ("thimble") shows wear around the edges.No other damage was reported.

• Brand Name: ENDO-MODEL MODULAR KNEE PROTHESIS SYSTEM
• Type of Device: ENDO-MODEL MODULAR KNEE PROTHESIS SYSTEM
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 17064444
• MDR Text Key: 316677220
• Report Number: 3006721341-2023-00012
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/19/2023,06/05/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/05/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15-3817/12
• Device Catalogue Number: 15-3817/12
• Device Lot Number: 200513
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/19/2023
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 05/19/2023
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 58 YR
• Patient Sex: Male