MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM; ROTATIONAL KNEE JOINT PROSTHESIS,TIBIAL COMPONENT

Model Number 15-2814/03

Device Problem Material Separation (1562)

Patient Problem Insufficient Information (4580)

Event Date 02/09/2022

Event Type  Injury  

Event Description

Sales representative reported that he was called in to or because the surgeon (dr.(b)(6)) needed to swap out a poly piece from tibial component that was implanted on (b)(6) 2021.When sales rep arrived in the or, he learned from surgeon's nurse that poly was loose, and the screw was floating.Additionally, the nurse stated that there may have been cement on the tibia baseplate.Surgeon examined the tibia and realized that the tip of the poly locking screw had broken off in the screw hole of the tibia.Surgeon was able to remove the baseplate without taking the stem out and replaced the tibial component.Per sales rep and surgeons nurse, they both believe that the poly was not engaged properly, and the screw was forced in and potentially caused the loosening.

• Brand Name: ENDO-MODEL MODULAR KNEE PROSTHESIS SYSTEM
• Type of Device: ROTATIONAL KNEE JOINT PROSTHESIS,TIBIAL COMPONENT
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 13726315
• MDR Text Key: 287027369
• Report Number: 3006721341-2022-00002
• 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
• Type of Report: Initial
• Report Date: 03/03/2022,02/09/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/10/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 15-2814/03
• Device Catalogue Number: 15-2814/03
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Distributor Facility Aware Date: 02/09/2022
• Device Age: 1 YR
• Date Report to Manufacturer: 03/03/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 41 YR
• Patient Sex: Male