KALIX FLAT FOOT IMPLANT EXTERNAL DIAM. 11MM
Received Apr 2, 2007 · Event occurred Apr 10, 2006
Report 9615741-2007-00016 · MDR key 834768
Device
Product problems
- Replace
- Device Slipped
- Fitting Problem
- Implant, repositioning of
Patient
*
- Surgery, prolonged
- Surgical procedure, additional
Narrative
Description of Event or Problem
DURING A SURGERY, THE PHYSICIAN PLACED A KALIX I IMPLANT (SIZE 11). THE IMPLANT IS LOCKED, BUT THE PHYSICIAN DID NOT FEEL THAT IT WAS WELL-IMPLANTED. SO , THE PHYSICIAN WANTED TO RE-IMPACT THE IMPLANT. THE TITANIUM PORTION WAS UNSCREWED FROM THE POLYETHYLENE PORTION. THE IMPLANT WAS REPOSITIONED. WHEN THE TITANIUM PORTION WAS INSERTED BACK INTO THE POLYETHYLENE PORTION, IT SLIPPED THROUGH. THE POLYETHYLENE PART HAD EXPANDED AND THE TITANIUM COULD NOT BE RE-FITTED OR SCREWED BACK IN TO THE POLYETHYLENE. THE POLYETHYLENE PART WAS TAKEN OUT THROUGH THE PREVIOUS INCISION. THE PHYSICIAN HAD TO CUT ANOTHER LITTLE INCISION (ON THE INTERNAL FACE) TO REMOVE THE TITANIUM PART FROM THE PATIENT. THE PHYSICIAN SUCCESSFULLY PLACED ANOTHER IMPLANT (BIGGER SIZE, SIZE 12). THE SURGERY TIME HAS BEEN INCREASED LESS THAN 10 MINUTES.
Additional Manufacturer Narrative
THE PRODUCT WAS NOT RETURNED FOR EVALUATION. THE USER FACILITY PROVIDED THE LOT NUMBER. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED AND FOUND NO ANOMALIES DURING THE MANUFACTURING PROCESS. THE COMPLAINTS DATABASE WERE REVIEWED. SINCE 2000, NINE COMPLAINTS WERE RECEIVED FOR THIS PRODUCT, CONCERNING THE ELEMENTS COMING APART. BASED UPON THE REPORTED INCIDENT AND DUE TO THE LACK OF PRODUCT RETURN, THE EXACT ROOT CAUSE COULD NOT BE DETERMINED.