MAUDE Adverse Event Report: WALDEMAR LINK GMBH & CO. KG ENDO-MODEL M ROTATIONAL KNEE JOINT PROSTHESIS,TIBIAL COMPONENT; UNCOATED KNEE TIBIA/INSERT PROSTHESIS

Catalog Number 15-2814/03

Device Problems Break (1069); Fracture (1260); Loose or Intermittent Connection (1371)

Patient Problem Failure of Implant (1924)

Event Date 02/09/2022

Event Type  Injury  

Event Description

It was reported that the sales representative 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.

Event Description

It was reported that the sales representative was called in to or because the surgeon (dr.S) 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 M ROTATIONAL KNEE JOINT PROSTHESIS,TIBIAL COMPONENT
• Type of Device: UNCOATED KNEE TIBIA/INSERT PROSTHESIS
• Manufacturer (Section D): WALDEMAR LINK GMBH & CO. KG; barkhausenweg 10; hamburg, 22339 ; GM 22339
• Manufacturer Contact: annerike tizia hucklenbroch ; barkhausenweg 10; hamburg, 22339 ; GM 22339
• MDR Report Key: 13756207
• MDR Text Key: 287107542
• Report Number: 3004371426-2022-00002
• Device Sequence Number: 1
• Product Code: KRO
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K143179
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Distributor
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/03/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/14/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 15-2814/03
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/03/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 02/01/2021
• 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: 41 YR
• Patient Sex: Male