HMRS ROT HINGE TIB ROT COMP

Additional Manufacturer Narrative

A SUPPLEMENTAL REPORT WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION. THE SUBJECT DEVICE IS NOT CLEARED FOR SALE IN THE U.S., BUT A SIMILAR DEVICE IS COMMERCIALLY AVAILABLE IN THE U.S.

Description of Event or Problem

THE PHARMACIST AT THE CLINIC, REPORTED THE FOLLOWING EVENT: "FRACTURE OF THE TOTAL KNEE PROSTHESIS WHEN PATIENT WAS AT HOME. PAIN FURTHER TO THE FRACTURE AND LATERAL DISLOCATION OF THE PATELLA. REVISION TO CHANGE THE ENTIRE PROSTHESIS FOR A FIXED HINGE PROSTHESIS."

Additional Manufacturer Narrative

THE PATIENT IS (B)(6). AN EVENT REGARDING COMPONENT FRACTURE INVOLVING AN HMRS TIBIAL ROTATING COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. DEVICE EVALUATION AND RESULTS: THE STEMMED PORTION OF THE TIBIAL BEARING COMPONENT IS ENTIRELY FRACTURED DUE TO FATIGUE AND FINAL DUCTILE FRACTURE. BOTH THE SUPERIOR AND INFERIOR SURFACES ARE DAMAGED DUE TO REPEATED CONTACT WITH THE FEMORAL COMPONENT AT HYPER-EXTENSION AND THE METAL BASEPLATE AFTER INSERT DISASSOCIATION RESPECTIVELY. THE BASE ALLOY OF THE BROKEN PART CONFORMS TO SPECIFICATION. NO MATERIAL OR MANUFACTURING DEFECTS WERE OBSERVED ON THE SURFACES EXAMINED. A REVIEW OF THE PROVIDED X-RAYS, OPERATIVE REPORTS, PATIENT HISTORY REPORTS, AND MATERIAL ANALYSIS REPORT BY A CLINICAL CONSULTANT INDICATED: ¿AFTER ELEVEN YEARS IN SITU FOR A TUMOR SALVAGE SURGERY WITH A DISTAL FEMORAL REPLACEMENT ROTATING HINGE TOTAL KNEE ARTHROPLASTY, FATIGUE FRACTURE OF THE HINGED POST WAS NOT UNEXPECTED.¿ INDICATED THAT THE DAMAGES TO THE COMPONENTS WERE NOT UNCOMMON FOR THE NATURE OF THE PROCEDURE AND THE AMOUNT OF TIME THAT THE COMPONENTS WERE IMPLANTED. DEVICE HISTORY REVIEW: THE DEVICE WAS MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. COMPLAINT HISTORY REVIEW: THERE HAVE BEEN NO OTHER EVENTS FOR THE LOT REFERENCED. CONCLUSIONS: THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE THE ANTERIOR LOADING CAUSED BY REPEATED HYPER EXTENSION IN THE KNEE JOINT NOTED IN THE MATERIAL ANALYSIS REPORT COULD HAVE CONTRIBUTED TO THE FRACTURE OF THE TIBIAL ROTATING COMPONENT.

Description of Event or Problem

THE PHARMACIST AT THE CLINIC, REPORTED THE FOLLOWING EVENT : "FRACTURE OF THE TOTAL KNEE PROSTHESIS WHEN PATIENT WAS AT HOME. PAIN FURTHER TO THE FRACTURE AND LATERAL DISLOCATION OF THE PATELLA. REVISION TO CHANGE THE ENTIRE PROSTHESIS FOR A FIXED HINGE PROSTHESIS."