QUADRA H FEMORAL STEMS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 11 JUNE 2026 STEM: QUADRA-H 01.12.98SN QUADRA & QUOT; H & QUOT; SHORT NECK, CEM.LESS, STD, S.00 (K121011) LOT: 2107742: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-NOV-2021. EXPIRATION DATE: 26-OCT-2026. 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. CLINICAL EVALUATION FOUR YEARS AFTER A PRIMARY CEMENTLESS THA IN AN OVERWEIGHT FEMALE PATIENT, THE ENTIRE HIP CONSTRUCT WAS REVISED FOLLOWING REPORTS OF PERSISTENT PAIN OVER THE PRECEDING YEAR. THE STEM WAS CLEARLY LOOSE PROXIMALLY; HOWEVER, INSUFFICIENT INFORMATION IS AVAILABLE TO DETERMINE WHY THE ACETABULAR COMPONENT WAS REVISED AS WELL. THE STEM ALSO APPEARS RELATIVELY SMALL (NOT NECESSARILY UNDERSIZED, BUT SMALL), AND IT IS UNKNOWN WHETHER THE PATIENT & SIZE 39; S BODY MASS INDEX CHANGED SIGNIFICANTLY SINCE 2022. THERE IS NO REASON TO SUSPECT THAT THIS ADVERSE EVENT WAS CAUSED BY A DEFECT OR MALFUNCTION OF THE IMPLANTED DEVICES. FAILURE OF OSSEOINTEGRATION, OR MORE LIKELY LOSS OF OSSEOINTEGRATION, IS WELL DOCUMENTED IN THE LITERATURE AND IS COMMONLY CLASSIFIED AS ASEPTIC LOOSENING. ROOT CAUSE: BASED ON THE INFORMATION AVAILABLE, NO DEFINITIVE ROOT CAUSE CAN BE ESTABLISHED. THERE IS NO INDICATION THAT ANY POTENTIAL ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DEVICE HISTORY RECORD REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED ISSUE.

Description of Event or Problem

PRIMARY HIP SURGERY WAS PERFORMED ON (B)(6) 2022. APPROXIMATELY ONE YEAR BEFORE THE REVISION SURGERY, THE PATIENT REPORTED THE ONSET OF MID-THIGH PAIN AND INITIALLY CONSULTED THEIR LOCAL DOCTOR, RECEIVING PAIN MANAGEMENT AND PHYSIOTHERAPY BEFORE BEING REVIEWED BY AN ORTHOPAEDIC CONSULTANT. DURING THE CLINICAL INVESTIGATION, THE REVISION SURGEON NOTED PROXIMAL LOOSENING ON X-RAY, REFERRING TO THE FEMORAL STEM. BASED ON THESE FINDINGS, THE SURGEON DECIDED TO REMOVE THE STEM AND CHANGE THE CUP SIZE, AS THE PATIENT WAS CONSIDERED TO BE AT INCREASED RISK OF DISLOCATION DUE TO OBESITY. REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DURING WHICH ALL IMPLANTS WERE REPLACED WITH COMPETITOR DEVICES ACCORDING TO THE SURGEON`S PREFERENCE, WITH IMPLANTATION OF A SIZE 50 COMPETITOR DUAL MOBILITY CUP.