MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL SL KNEE PROSTHESIS SYSTEM; DISTAL FEMORAL REPLACEMENT COMPONENTS,MODULAR

Model Number 16-2853/21

Device Problem Appropriate Term/Code Not Available (3191)

Patient Problem Failure of Implant (1924)

Event Type  Injury  

Event Description

On (b)(6) 2022, lb become aware of a junction failure of the proximal femoral component and distal femoral stem segment, which per sales rep happened in early december 2021.The revision surgery performed on (b)(6) 2021 was successful.

• Brand Name: ENDO-MODEL SL KNEE PROSTHESIS SYSTEM
• Type of Device: DISTAL FEMORAL REPLACEMENT COMPONENTS,MODULAR
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 14346828
• MDR Text Key: 291348728
• Report Number: 3006721341-2022-00004
• Device Sequence Number: 1
• Product Code: KRO
• UDI-Device Identifier: 04026575383306
• UDI-Public: 04026575383306
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/04/2022,05/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/30/2022
• Device Model Number: 16-2853/21
• Device Catalogue Number: 16-2853/21
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 05/03/2022
• Date Report to Manufacturer: 05/04/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 72 YR
• Patient Sex: Male