TIBIAL COMP KIN HINGE KNEE
Received Jul 31, 2014 · Event occurred Jul 9, 2014
Report 0002249697-2014-02924 · MDR key 3969937
Device
Product problems
- Loose or Intermittent Connection
Patient
53 YR
- No Code Available
Narrative
Description of Event or Problem
PATIENT HAD A PRIMARY OF LEFT KNEE IN 1995 BY DR. (B)(6). PATIENT THEN HAD A REVISION TO REPLACE POLYETHYLENE ON (B)(6) 2006. PATIENT IS NOW ON SECOND REVISION OF LEFT KNEE DUE TO LOOSE COMPONENTS. IT WAS REPORTED THAT THE FEMUR AND TIBIA WERE LOOSE. NO FURTHER INFO AVAILABLE DUE TO DR AND HOSPITAL POLICY.
Additional Manufacturer Narrative
AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION WAS REQUESTED AND IF IT BECOMES AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. HOSPITAL POLICY.
Additional Manufacturer Narrative
AN EVENT REGARDING FEMORAL AND TIBIAL LOOSENING INVOLVING A KRH TIBIAL BEARING COMPONENT WAS REPORTED. THE MRS SYSTEM IS A SEGMENTAL MODULAR SYSTEM. THE REPORTED FEMORAL AND TIBIAL LOOSENING WOULD OCCUR AT THE MODULAR STEM / BONE INTERFACE. BASED ON THE LIMITED INFORMATION PROVIDED, THERE IS NO INDICATION OR ALLEGATION THAT LOOSENING OCCURRED BETWEEN THE TIBIAL BEARING COMPONENT AND ITS INTERFACING DEVICES. OTHER THAN THE MODULAR STEM, NO OTHER DEVICES INTERFACE WITH BONE. THERE IS NO INDICATION THAT THE PRODUCT REPORTED IN THIS INVESTIGATION MAY HAVE CONTRIBUTED TO THE EVENT. NO FURTHER INVESTIGATION IS REQUIRED AT THIS TIME.
Description of Event or Problem
PATIENT HAD A PRIMARY OF LEFT KNEE IN 1995 BY DR. (B)(6) PATIENT THEN HAD A REVISION TO REPLACE POLYETHYLENE ON (B)(6) 2006. PATIENT IS NOW ON SECOND REVISION OF LEFT KNEE DUE TO LOOSE COMPONENTS. IT WAS REPORTED THAT THE FEMUR AND TIBIA WERE LOOSE. NO FURTHER INFO AVAILABLE DUE TO DR AND HOSPITAL POLICY.