BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA P FEMORAL STEMS

    MDR report key: 21033879 · Received December 30, 2024

    Report

    Report Number
    3005180920-2024-01042
    Event Type
    Injury
    Date Received
    December 30, 2024
    Date of Event
    December 10, 2024
    Report Date
    December 30, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720571
    PMA / PMN Number
    K181254
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 17-DEC-2024. LOT 2200473: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-JUN-2022. EXPIRATION DATE: 2027-05-29. 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. ADDIITONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 17-DEC-2024. LINER: VERSAFITCUP DM 01.26.2856MHC DOUBLE MOBILITY HC LINER Ø 56/28 (K143453) LOT. 2302834 LOT 2302834: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-03-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.230H HEAD BIOLOX OPTION Ø 28 (K131518) LOT. 2315673 LOT 2315673: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JUL-2023. EXPIRATION DATE: 2028-06-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.156MB DOUBLE MOBILITY ACETABULAR SHELL Ø56 (K143453) LOT. 2246659 LOT 2246659: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAY-2023. EXPIRATION DATE: 2028-05-16. 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.

    Description of Event or Problem · 0

    AT ABOUT 3 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL MEDACTA HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2433896 QUADRA P FEMORAL STEMS QUADRA-P LAT STEM SIZE 5 LZO MEDACTA INTERNATIONAL SA 01.12.145 2200473 07630040720571

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Male Required Intervention