BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA H FEMORAL STEMS

    MDR report key: 24631234 · Received March 18, 2026

    Report

    Report Number
    3005180920-2026-00214
    Event Type
    Injury
    Date Received
    March 18, 2026
    Date of Event
    February 16, 2026
    Report Date
    March 18, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802041
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 13 MARCH 2026 STEM: QUADRA-H 01.12.023 QUADRA STEM STANDARD HAP 12/14 S.3 (K082792) LOT 091116: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-JUN-2009. EXPIRATION DATE: 30-APR-2014. 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. CUP: VERSAFITCUP 01.26.52MB VERSAFITCUP METALBACK DM D 52 MM (K083116) LOT 090910: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-JUN-2009. EXPIRATION DATE: 31-MAY-2014. 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 16 YEARS AFTER PRIMARY CEMENTLESS THA THE STEM GETS LOOSE AND NEEDS REVISION. DURING SURGERY, THE DUAL MOBILITY CUP WAS ALSO EXCHANGED FOR A FIXED CUP WITH A LARGE HEAD. THE STEM POSITION IS SLIGHTLY VALGUS, IN A SMALL FEMUR OF CYLINDRICAL SHAPE, BUT AS IT LASTED 16 YEARS, IT WAS PRESUMABLY SATISFACTORY. THE BONE MAY HAVE CHANGED IN SHAPE AND DENSITY AND THE STEM COULD NOT REMAIN IN THE SAME POSITION, HENCE THE LOOSENING. NO SIGNS OF OSTEOLYSIS AND THE SURGEON SUBJECTIVELY REPORTS NO SIGNS OF ABNORMAL WEAR. NO REASON TO SUSPECT A DEFECTIVE OR DETERIORATED IMPLANT AT THE ORIGIN OF THE ADVERSE EVENT. ROOT CAUSE:ASEPTIC LOOSENING 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. THE BONE MAY HAVE CHANGED IN SHAPE AND DENSITY AND THE STEM COULD NOT REMAIN IN THE SAME POSITION, HENCE THE LOOSENING. NO SIGNS OF OSTEOLYSIS AND THE SURGEON SUBJECTIVELY REPORTS NO SIGNS OF ABNORMAL WEAR.

    Description of Event or Problem · 0

    AT ABOUT 16 YEARS AND1 MONTHFROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE CAUSE WAS DUE TO A LOOSE STEM ANDACETABULAR CUP. THE SURGEON REVIEWED THE BONE SCAN AND VERIFIED THE LOOSE IMPLANT AND DETERMINED THAT A TOTAL HIP REVISION WAS NECESSARY. THE SURGEON REVISED THE QUADRA STANDARD STEM TO A QUADRA-P COLLARED STEM, THE 28MM BIOLOX HEAD TO A 40MM BIOLOX HEAD M, THE VERSAFITCUP DM 52MM TO A MPACT D 54 CUP, AND THE VERSAFITCUP LINER 52MM X 28 TO A D 40/F MPACT LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    694128 QUADRA H FEMORAL STEMS QUADRA STEM STANDARD HAP 12/14 S.3 JDI MEDACTA INTERNATIONAL SA 01.12.023 091116 07630030802041

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Female Required Intervention