QUADRA H FEMORAL STEMS

Additional Manufacturer Narrative

BATCH REVIEW PERFORMED ON 16 JUNE 2026 STEM: QUADRA-H 01.12.024 QUADRA STEM STANDARD HAP 12/14 S.4 (K082792) LOT 184777: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-OCT-2018. EXPIRATION DATE: 21-OCT-2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ONE SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CLINICAL EVALUATION 7 YEARS AFTER PRIMARY CEMENTLESS THA, THE PATIENT FEELS PAIN WHEN THE FEMUR IS SUBJECT TO MECHANICAL STRESS. THIS IS HIGHLY SUGGESTIVE OF A MOBILIZED FEMORAL COMPONENT, AND THE SUSPECT IS CONFIRMED BY IMAGING. REVISION SURGERY IS UNDERTAKEN. THE CAUSE IS PROBABLY ASEPTIC LOOSENING, BECAUSE THERE IS NO MENTION OF PROVEN SEPSIS. THE RATHER CONTINUOUS RADIOLUCENT LINE ALL AROUND THE STEM IS QUITE PECULIAR IN ABSENCE OF AN INFECTION. NO OSTEOLYTIC REACTIONS, NO CORTICAL THICKENING OR EVIDENT STRESS SHIELDING. SOME CASES OF "SILENT LATE INFECTIONS" HAVE BEEN REPORTED, BUT OF COURSE WE HAVE NOT ENOUGH INFORMATION TO IMPLY THAT THIS COULD BE ONE SUCH CASE. WE COULD NOT ESTABLISH A DEFINITE ROOT CAUSE FOR THE LOOSENING. 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 7 YEARS AND 4 MONTHS FROM THE PRIMARY, THE PATIENT PRESENTED WITH SEVERE PAIN DUE TO LOOSENING OF THE STEM OF A RIGHT TOTAL HIP REPLACEMENT. NO TRAUMA WAS REPORTED. MRI AND CT SCANS SHOWED A RADIOLUCENT LINE AROUND THE STEM, SUPPORTING THE DIAGNOSIS OF FEMORAL STEM LOOSENING IN CORRELATION WITH THE PATIENT`S PAIN AND FUNCTIONAL LIMITATIONS. THE SURGEON REVISED THE QUADRA-H STEM WITH A COMPETITOR STEM AND REVISED THE FEMORAL HEAD, WHILE THE ACETABULAR SHELL AND LINER WERE RETAINED.