WALDEMAR LINK GMBH & CO. KG ENDO-MODEL M ROTATIONAL KNEE JOINT PROSTHESIS,TIBIAL COMPONENT; UNCOATED KNEE TIBIA/INSERT PROSTHESIS
|
Back to Search Results |
|
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.
|
|
Search Alerts/Recalls
|
|
|