BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-P STD STEM SIZE 2

    MDR report key: 20167706 · Received September 9, 2024

    Report

    Report Number
    3005180920-2024-00731
    Event Type
    Injury
    Date Received
    September 9, 2024
    Date of Event
    August 13, 2024
    Report Date
    September 9, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040720434
    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 23 AUGUST 2024: LOT 2111495: (B)(4) MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. ADDITIONAL IMPLANTS INVOLVED; BATCH REVIEW PERFORMED ON 23 AUGUST 2024: LINER: MPACT 01.26.2852MHC DOUBLE MOBILITY HC LINER 28/DMF (K092265) LOT 2402134: (B)(4) MANUFACTURED AND RELEASED ON 14-DEC-2021. EXPIRATION DATE: 2026-11-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115) LOT 2411634: (B)(4) MANUFACTURED AND RELEASED ON 10-MAY-2024. EXPIRATION DATE: 2029-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW. CUP: MPACT 01.32.152MB DOUBLE MOBILITY ACETABULAR SHELL Ø52 (K143453) LOT 2402631: (B)(4) MANUFACTURED AND RELEASED ON 10-JULY-2024. EXPIRATION DATE: 2029-04-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 4 DAYS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA HARDWARE AND REIMPLANTED PERMANENT PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2021719 QUADRA-P STD STEM SIZE 2 HIP STEM LZO MEDACTA INTERNATIONAL SA 2111495 07630040720434

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR Female Required Intervention