IBALANCE PATELLA IMPLANT DOME, 30 X 8 MM

Description of Event or Problem

ON (B)(6) 2024, IT WAS REPORTED BY A PATIENT VIA PHONE THAT THE PATIENT HAD SURGERY ON (B)(6) 2018 FOR A RIGHT KNEE PATELLOFEMORAL JOINT REPLACEMENT. AFTER THE SURGERY, THE PATIENT EXPERIENCED PAIN WHEN LYING DOWN AND LATER ON EXPERIENCED SHARP PAIN IN THE BACK OF THE LEG WHEN GOING UP THE STAIRS WITH THE PATIENT'S LEG GIVING OUT. AN X-RAY WAS PERFORMED AFTERWARD AND SHOWED THAT THE UNKNOWN ARTHREX PART NUMBER THAT WAS IMPLANTED ON (B)(6) 2018 HAD COME APART/BROKEN. PER THE PATIENT, THE SURGEON STATED THIS WAS NOT NORMAL AND PERFORMED AN ARTHROPLASTY TOTAL REVISION SURGERY ON THE RIGHT KNEE ON (B)(6) 2024 TO REMOVE THE BROKEN PART AND PUT A NEW PART IN. BOTH SURGERIES WERE PERFORMED BY THE SAME SURGEON AT DIFFERENT FACILITIES. ADDITIONAL INFORMATION RECEIVED ON 9/5/2024: THE MEDICAL RECORDS INDICATE THAT THE PATIENT DID WELL FOLLOWING HIS 2018 SURGERY UNTIL HE FIRST EXPERIENCED RIGHT POSTERIOR KNEE PAIN ABOUT A YEAR AGO. THE PATIENT REPORTED THAT THERE WAS NO PRECEDING INJURY OR TRAUMA. THE PATIENT BELIEVES THE PAIN BEGAN SHORTLY AFTER RECEIVING STEM CELL INJECTIONS ON THE RIGHT FOOT. THE PATIENT'S SYMPTOMS WORSENED ON (B)(6) 2024 THE PATIENT EXPERIENCED SHARP PAIN IN THE BACK OF THE LEG WHEN GOING UP THE STAIRS AND REPORTED THAT HE WAS UNABLE TO BEAR WEIGHT. THE MEDICAL RECORDS INDICATE THE PATIENT HAD SWELLING AND INABILITY TO EXTEND THE RIGHT KNEE FULLY BUT NO REDNESS OR WARMTH OF THE JOINT. ON (B)(6) 2024, AN X-RAY OF THE PATIENT'S RIGHT KNEE WAS TAKEN, WHICH SHOWED EVIDENCE OF PRESUMED ACUTE HARDWARE FRACTURE AND MODERATE KNEE JOINT EFFUSION. ON (B)(6) 2024, A CT SCAN CONFIRMED FRACTURED CAUDAL ASPECT OF THE FEMORAL COMPONENT OF THE PATELLOFEMORAL ARTHROPLASTY, THAT THE FRACTURED HARDWARE FRAGMENT IS DISPLACED INFERIORLY, LOCATED IN THE MEDIAL COMPARTMENT JOINT SPACE, AND THAT THERE IS NO SIGNIFICANT LUCENCY SURROUNDING THE HARDWARE TO SUGGEST LOOSENING OR INFECTION. ADDITIONAL INFORMATION RECEIVED ON 9/6/2024: DURING THE RIGHT KNEE PATELLOFEMORAL JOINT REPLACEMENT PROCEDURE ON (B)(6) 2018, AN AR-502-4R BALANCE PFJ, PATELLOFEMORAL IMPLANT, AND AN AR-504-PSB8 IBALANCE TKA PATELLA IMPLANT WERE IMPLANTED. THE PATIENT¿S OFFICE VISIT RECORDS FROM (B)(6) 2018 INDICATE THAT THE PATIENT UNDERWENT A RIGHT KNEE ARTHROSCOPY PROCEDURE ON (B)(6) 2018.

Additional Manufacturer Narrative

INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: B1, D9, G3, H3, H6. THE AR-502-4R DEVICE WAS RECEIVED BY ARTHREX ON JULY 3, 2025. ARTHREX CONDUCTED NON-DESTRUCTIVE FAILURE ANALYSIS ACTIVITIES AND CONCLUDES THE FOLLOWING REGARDING THE SUBJECT DEVICE: (1) THE COMPOSITION OF THE DEVICE WAS IN ALIGNMENT WITH ASTM F75; (2) A MEDIAL-LATERAL CRACK SPANNING THE FRACTURE SURFACE ALONG WITH OBSERVED FATIGUE STRIATIONS AND SIGNS OF MULTIPLE ORIGIN POINTS SUGGEST THE FAILURE WAS FATIGUE; AND (3) THE MEDIAL-LATERAL CRACK SPANNING THE FRACTURE SURFACE, THE CRACKS NOTED ON THE ARTICULATING AND NON-ARTICULATING SIDES, AND THE ASYMMETRY OF THE FRACTURE SURFACE ON THE ARTICULATING AND NON-ARTICULATING SIDES SUGGEST THAT A MIXED MODE OF FRACTURE OCCURRED, WHERE THE FATIGUE LOADING PROFILE WAS SUSPECTED TO BE MULTIAXIAL, COMPRISED OF AXIAL TENSION-COMPRESSION WITH PARTIALLY REVERSED BENDING. IN SUMMARY, ARTHREX FINDS THAT RATHER THAN BEING METALLURGICAL OR DESIGN-RELATED, THE FAILURE WAS MOST LIKELY THE RESULT OF OVERDISTALIZATION OF THE PATELLOFEMORAL COMPONENT, A SUBOPTIMAL IMPLANT POSITION NOTED IN THE OPERATIVE REPORT, THAT CREATED A BENDING MOMENT NEAR THE DISTAL END THAT EXPOSED THE IMPLANT TO EXCESSIVE AND UNSUPPORTED TENSILE AND COMPRESSIVE FORCES CYCLICALLY DURING THE NORMAL KNEE MOTION.