IBALANCE PATELLA IMPLANT DOME, 34 X 9 MM

Additional Manufacturer Narrative

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

Description of Event or Problem

ON 5/13/2025, A SALES REPRESENTATIVE REPORTED VIA EMAIL THAT A PATIENT WHO UNDERWENT AN IBALANCE PROCEDURE HAS EXPERIENCED LOOSE IMPLANTS POST-SURGERY. DURING THE INITIAL SURGERY, AN AR-516-4R IBALANCE CEMENTED TKA FEMORAL IMPLANT PS, AN AR-503-TTTG IBALANCE CEMENTED TKA TIBIAL TRAY IMPLANT, AN AR-504-PSC9 IBALANCE DOMETKA PATELLA IMPLANT, AND AN AR-513-BG13 IBALANCE PS TKA TIBIAL BEARING IMPLANT WERE USED. ADDITIONAL INFORMATION WAS RECEIVED ON 5/21/2025: THE ORIGINAL SURGERY TOOK PLACE ON (B)(6) 2015 AND THE PATIENT LOOSE IMPLANTS WERE NOTICED AROUND (B)(6) 2025. ADDITIONAL INFORMATION RECEIVED ON 5/22/2025: A REVISION SURGERY HAS NOT OCCURRED. THE PATIENT IS DOING WELL; HOWEVER, WANTS THE ISSUE RESOLVED.

Additional Manufacturer Narrative

ADDITIONAL INFORMATION: G3, H3, H6. BASED ON THE INFORMATION PROVIDED WHICH MAY INCLUDE THE DEVICE (IF AVAILABLE AND RETURNED), PICTURES, VIDEOS, EVENT DESCRIPTION, AND ANY ADDITIONAL INFORMATION FROM THE FIELD, ARTHREX WAS ABLE TO CONCLUDE A MOST LIKELY CAUSE. THE MOST LIKELY CAUSE FOR THE REPORTED FAILURE CAN BE ATTRIBUTED TO A PATIENT-SPECIFIC EVENT. PER DFU-0183-3: "C. CONTRAINDICATIONS 1. INSUFFICIENT QUANTITY OR QUALITY OF BONE. 2. WHERE MATERIAL SENSITIVITY IS SUSPECTED, APPROPRIATE TESTS SHOULD BE MADE AND SENSITIVITY RULED OUT PRIOR TO IMPLANTATION. 3. ANY ACTIVE INFECTION OR BLOOD SUPPLY LIMITATIONS. 4. THE USE OF THIS DEVICE MAY NOT BE SUITABLE FOR PATIENTS WITH INSUFFICIENT OR IMMATURE BONE. THE PHYSICIAN SHOULD CAREFULLY ASSESS BONE QUALITY BEFORE PERFORMING ORTHOPEDIC SURGERY ON PATIENTS WHO ARE SKELETALLY IMMATURE. THE USE OF THIS MEDICAL DEVICE AND THE PLACEMENT OF HARDWARE OR IMPLANTS MUST NOT BRIDGE, DISTURB OR DISRUPT THE GROWTH PLATE. 5. CONDITIONS THAT TEND TO LIMIT THE PATIENT¿S ABILITY OR WILLINGNESS TO RESTRICT ACTIVITIES OR FOLLOW DIRECTIONS DURING THE HEALING PERIOD. 6. DO NOT USE FOR SURGERIES OTHER THAN THOSE INDICATED. 7. AN OVERWEIGHT OR OBESE PATIENT CAN PRODUCE LOADS ON THE PROSTHESIS WHICH CAN LEAD TO FAILURE OF FIXATION OR FAILURE OF THE DEVICE ITSELF. 8. SEVERE DEFORMITY AND/OR RECURRENT SUBLUXATION OF THE KNEE JOINT. 9. INFLAMMATORY ARTHRITIS CONDITIONS, PARTICULARLY RHEUMATOID ARTHRITIS. 10. LIGAMENTOUS INSTABILITY OR SOFT-TISSUE LAXITY SUCH THAT THE POSTOPERATIVE STABILITY AFFORDED BY THE PROSTHESIS MAY BE COMPROMISED OR DISLOCATED.