BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA P FEMORAL STEMS

    MDR report key: 23758555 · Received December 9, 2025

    Report

    Report Number
    3005180920-2025-01232
    Event Type
    Injury
    Date Received
    December 9, 2025
    Date of Event
    November 25, 2025
    Report Date
    December 9, 2025
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040731898
    PMA / PMN Number
    K192827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 01 DECEMBER 2025. STEM: QUADRA-P COLLARED 01.12.165 QUADRA-P COLLARED STD. SIZE5 (K192827) LOT 2347077: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2024. EXPIRATION DATE: 01-APR-2029. 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: VERSAFITCUP DM 01.26.2852MHC DOUBLE MOBILITY HC LINER D 28/DMF (K092265) LOT 2408661: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-MAY-2024. EXPIRATION DATE: 30-APR-2029. 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 01.29.202 MECTACER HEAD BIOLOX DELTA DIA.28 12/14-M (K112115) LOT 2426868: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-OCT-2024. EXPIRATION DATE: 23-SEP-2029. 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. LINER: VERSAFITCUP DM 01.32.4452CF DM CONVERTER G/DMF - TIN COATED (K211891) LOT 2303420: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-JUL-2023. EXPIRATION DATE: 24-JUN-2028. 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 3D METAL 01.38.062DH MPACT 3D METAL SHELL TWO HOLE D 62MM (K171966) LOT 2000246: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 07-MAY-2020. EXPIRATION DATE: 28-APR-2025. 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

    AT ABOUT 10 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL IMPLANTS, AND IMPLANTED NEW HARDWARE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2590646 QUADRA P FEMORAL STEMS QUADRA-P COLLARED STD. SIZE5 LZO MEDACTA INTERNATIONAL SA 01.12.165 2347077 07630040731898

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Required Intervention