QUADRA H FEMORAL STEMS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 12 JUNE 2026 STEM: QUADRA-H 01.12.32SN QUADRA & QUOT; H & QUOT; SHORT NECK, CEM.LESS, LAT., HAP S.2 (K082792) LOT: 110960: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-MAY-2011. EXPIRATION DATE: APRIL 2016. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ROOT CAUSE: ASEPTIC LOOSENING IS POSSIBLE LITERATURE DESCRIBED ADVERSE EVENT AFTER PRIMARY JOINT ARTHROPLASTIES AND CAUSES ARE OFTEN UNKNOWN. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT AND THE INVESTIGATION DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE OR SYSTEMIC DEFICIENCY.

Description of Event or Problem

AT ABOUT 14 YEARS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA REPORTED. THE SURGEON REVISED THE MEDACTA STEM AND HEAD TO A COMPETITOR STEM AND HEAD AND REVISED THE MEDACTA DOUBLE MOBILITY 48/28 DIAMETER LINER TO A D 28/DMD DOUBLE MOBILITY LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.