BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA P FEMORAL STEMS

    MDR report key: 24964779 · Received April 23, 2026

    Report

    Report Number
    3005180920-2026-00344
    Event Type
    Injury
    Date Received
    April 23, 2026
    Date of Event
    March 31, 2026
    Report Date
    April 23, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040731973
    PMA / PMN Number
    K192827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 08 APR 2026 STEM: QUADRA-P COLLARED 01.12.182 QUADRA-P COLLARED LAT. SIZE2, LOT 2512602 (K192827): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-NOV-2025. EXPIRATION DATE: 2030-OCT-23. 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. BALL HEADS: MECTACER 01.29.208 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-S, LOT 2528818 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2025. EXPIRATION DATE: 2030-NOV-04. 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: MPACT 01.32.150DHT ACETABULAR SHELL D 50 TWO-HOLES T, LOT 2519643 (K230011): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2025. EXPIRATION DATE: 2030-SEP-24. 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. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER D 36/E, LOT 2521300 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2025. EXPIRATION DATE: 2030-SEP-14. 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: INFECTION IS A KNOWN POSSIBLE COMPLICATION OF ANY SURGERY. ALTHOUGH NO ROOT CAUSE CAN BE ESTABLISHED, THERE IS NO INDICATION THAT ANY ISSUE WITH THE DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO THE EVENT, AND THE DOCUMENT REVIEW DOES NOT INDICATE ANY POTENTIAL MANUFACTURING RELATED CAUSE.

    Description of Event or Problem · 0

    REVISION SURGERY DUE TO INFECTION AFTER 21 DAYS FROM PRIMARY SURGERY AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL HIP COMPONENTS TO ANTIBIOTIC SPACERS FOR A STAGE ONE REVISION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    249019 QUADRA P FEMORAL STEMS QUADRA-P COLLARED LAT. SIZE2 LZO MEDACTA INTERNATIONAL SA 01.12.182 2512602 07630040731973

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention