BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA P FEMORAL STEMS

    MDR report key: 24681022 · Received March 24, 2026

    Report

    Report Number
    3005180920-2026-00229
    Event Type
    Injury
    Date Received
    March 24, 2026
    Date of Event
    February 24, 2026
    Report Date
    March 24, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040731881
    PMA / PMN Number
    K192827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 03 MARCH 2026. STEM: QUADRA-P COLLARED 01.12.164 QUADRA-P COLLARED STD. SIZE 4 (K192827) LOT 2510361: (B)(4) ITEMS MANUFACTURED AND RELEASED 28-AUG-2025. EXPIRATION DATE: 05-AUG-2030. 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: A FEW DAYS AFTER PRIMARY CEMENTLESS THA, THE PATIENT COMPLAINS OF A FRACTURE AT THE LESSER TROCHANTER LEVEL, WITH NO REPORTED TRAUMA. IT IS CONCEIVABLE THAT THE BONE WAS DAMAGED DURING FEMORAL PREPARATION; THIS IS A POSSIBLE ADVERSE EVENT CONNECTED WITH THA, DESCRIBED IN THE INSTRUCTIONS FOR USE. NO REAL RADIOGRAPH WAS SUPPLIED; FROM THE INTRAOPERATIVE FLUOROSCOPIC IMAGE, A RATHER PECULIAR FEMORAL SHAPE CAN BE IMAGINED, AND THIS MAY HAVE CONTRIBUTED TO MAKING THE FEMORAL PREPARATION RATHER DIFFICULT AND RISKIER. IT SEEMS THAT THE SURGEON, A HIGHLY EXPERIENCED PROFESSIONAL IN TOTAL JOINT REPLACEMENT, PERFORMED A RATHER LOW RESECTION: THERE MUST BE A REASON FOR THIS CHOICE, BUT IT&SIZE39; S DIFFICULT TO TELL BECAUSE OF THE LACK OF IMAGES PROVIDED. NO REASON TO SUSPECT THAT THE ADVERSE EVENT WAS CAUSED BY A DEFECTIVE OR MALFUNCTIONING DEVICE. ROOT CAUSE: BONE FRACTURE IS A 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. NO PREVIOUS CASE HAS BEEN ADDRESSED TO A DEVICE DESIGN OR MANUFACTURING RELATED ROOT CAUSE.

    Description of Event or Problem · 0

    AT ABOUT 3 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING HIP PAIN DUE TO A FRACTURE OF THE LESSER TROCHANTER AND CALCAR BONE LOSS. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE QUADRA P SIZE4 STEM TO A QUADRA R SIZE 4 STEM AND THE BIOLOX 40MM HEAD M TO A BIOLOX 40MM HEAD S. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    742566 QUADRA P FEMORAL STEMS QUADRA-P COLLARED STD. SIZE4 LZO MEDACTA INTERNATIONAL SA 01.12.164 2510361 07630040731881

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Female Required Intervention