VERSAFITCUP CC TRIO ACETABULAR SYSTEM

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 17 JUNE 2026 LOT 131288: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-APR-2013. EXPIRATION DATE: 31-MAR-2018. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

Description of Event or Problem

PATIENT EXPERIENCED GRADUAL PROGRESSIVE PAIN IN THE LEFT HIP OVER THE PAST YEAR, RECENTLY AGGRAVATED BY AN INJURY, WITH PAINFUL CLICKING IN THE GROIN AREA AND ANTALGIC GAIT. CLINICAL EXAMINATION SHOWED PAIN DURING HIP MOTION WITHOUT RANGE OF MOTION LIMITATION. X-RAYS SHOWED WEAR OF THE LEFT ACETABULAR LINER, WHILE MRI SHOWED LOCAL SYNOVITIS WITH NO SIGNS OF IMPLANT LOOSENING. BLOOD TESTS WERE UNREMARKABLE. ABOUT 12 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, REVISION OF THE LEFT FEMORAL HEAD AND ACETABULAR LINER WAS PERFORMED, DURING WHICH EXTENSIVE VILLO-NODULAR SYNOVITIS, LINER WEAR AT THE 12 O`CLOCK AREA, AND A SMALL DARK SPOT ON THE FEMORAL HEAD WERE OBSERVED. NO IMPLANT LOOSENING WAS FOUND.