BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA R FEMORAL STEMS

    MDR report key: 24711327 · Received March 30, 2026

    Report

    Report Number
    3005180920-2026-00251
    Event Type
    Injury
    Date Received
    March 30, 2026
    Date of Event
    March 2, 2026
    Report Date
    March 27, 2026
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802447
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11 MARCH 2025. STEM: QUADRA -R 01.12.066 QUADRA R - STEM CEMENT-LESS HAP 12/14 S. 6 LOT 2112945 (K082792 AND K250450): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-FEB-2022. EXPIRATION DATE: 2027-JAN-25. 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 01.29.210 MECTACER HEAD BIOLOX DELTA DIA.36 12/14-L LOT. 2319276 (K112115): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2023. EXPIRATION DATE: 2028-AUG-16. 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. CUP: MPACT 01.32.160DH ACETABULAR SHELL D 60 TWO-HOLE LOT. 2208229 (K132879 AND K250450): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-SEP-2022. EXPIRATION DATE: 2027-AUG-21. 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 01.32.3652HCT MPACT FLAT LINER HC 36/G LOT. 2009615 (K103721): (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2020. EXPIRATION DATE: 2025-OCT-08. 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 1YEAR AND 10 MONTHS MONTH AFTER THE FIRST REVISION SURGERY. THE PATIENT HAD PRIMARY SURGERY USING COMPETITOR PRODUCTS. ON (B)(6) 2024, THE PATIENT WAS REVISED TO MEDACTA IMPLANTS. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS TO ADDRESS THE INFECTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    778147 QUADRA R FEMORAL STEMS QUADRA R - STEM CEMENT-LESS HAP 12/14 S. 6 JDI MEDACTA INTERNATIONAL SA 01.12.066 2112945 07630030802447

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Male Required Intervention