TIBIAL COMP KIN HINGE KNEE
Received Nov 13, 2014 · Event occurred Oct 16, 2014
Report 0002249697-2014-04253 · MDR key 4247837
Device
Product problems
- Loose or Intermittent Connection
- Fitting Problem
- Device-Device Incompatibility
Patient
58 YR
- No Code Available
Narrative
Additional Manufacturer Narrative
AN EVENT REGARDING TIBIAL COMPONENT LOOSENING DUE TO POOR BONE QUALITY INVOLVING A KRH TIBIAL ROTATING COMPONENT WAS REPORTED. CONCLUSION: THE INVESTIGATION IS ADDRESSED IN PR FOR THE KRH ALL-POLY TIBIAL COMPONENT. THE TIBIAL ROTATING COMPONENT DOES NOT INTERFACE WITH BONE, IT IS SEATED INTO THE ALL-POLY TIBIAL COMPONENT WHICH DOES INTERFACE WITH THE TIBIAL BONE. BASED ON THE PROVIDED INFORMATION, PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.
Description of Event or Problem
ON (B)(6) 2014, A PATIENT (NAME WITHHELD) HAD AN ISSUE WITH THE GMRS OR MRH KNEE REPLACEMENT. THE PATIENT'S FEMUR WAS FINE, BUT THE TIBIA FAILED. A SALES REPRESENTATIVE STATED THAT THE NEW COMPONENTS OF THIS PRODUCT WOULD FIT INTO THE OLD FEMUR; HOWEVER, THEY DID NOT. THE SURGEON HAD TO USE MULTIPLE 14-YEAR OLD COMPONENTS IN ORDER TO FINISH UP THE PATIENT'S PROCEDURE. THE PATIENT IS NOW AT A HIGHER RISK FOR INFECTION AND OTHER COMPLICATIONS DUE TO THIS. UPDATE AS PER SALES REP, DOA (B)(6) 2014: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POOR BONE QUALITY WHICH LED TO THE TIBIA BECOMING LOOSE (THERE WAS NO PRODUCT FAILURE). DURING THE REVISION SURGERY, THE GMRS BUSHINGS PROVIDED WERE NOT COMPATIBLE WITH THE FEMUR. THE OLD BUSHINGS FROM THE PRIMARY SURGERY HAD TO BE USED TO COMPLETE THE SURGERY.
Description of Event or Problem
ON (B)(6) 2014, A PATIENT (NAME WITHHELD) HAD AN ISSUE WITH THE GMRS OR MRH KNEE REPLACEMENT. THE PATIENT'S FEMUR WAS FINE, BUT THE TIBIA FAILED. A SALES REPRESENTATIVE STATED THAT THE NEW COMPONENTS OF THIS PRODUCT WOULD FIT INTO THE OLD FEMUR; HOWEVER, THEY DID NOT. THE SURGEON HAD TO USE MULTIPLE 14-YEAR OLD COMPONENTS IN ORDER TO FINISH UP THE PATIENT'S PROCEDURE. THE PATIENT IS NOW AT A HIGHER RISK FOR INFECTION AND OTHER COMPLICATIONS DUE TO THIS. UPDATE AS PER SALES REP, DOA (B)(6) 2014: IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO POOR BONE QUALITY WHICH LED TO THE TIBIA BECOMING LOOSE (THERE WAS NO PRODUCT FAILURE). DURING THE REVISION SURGERY, THE GMRS BUSHINGS PROVIDED WERE NOT COMPATIBLE WITH THE FEMUR. THE OLD BUSHINGS FROM THE PRIMARY SURGERY HAD TO BE USED TO COMPLETE THE SURGERY.
Additional Manufacturer Narrative
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE NOT AVAILABLE.