BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STEM: QUADRA-P COLLARED STD STEM SIZE 4

    MDR report key: 18612969 · Received January 31, 2024

    Report

    Report Number
    3005180920-2024-00019
    Event Type
    Injury
    Date Received
    January 31, 2024
    Date of Event
    January 9, 2024
    Report Date
    January 31, 2024
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630040731881
    PMA / PMN Number
    K192827
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 11-JAN-2024. LOT 2249416: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2023. EXPIRATION DATE: 2028-04-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. ADDITIONAL COMPONENTS INVOLVED IN THE EVENT: BATCH REVIEW PERFORMED ON 11-JAN-2024. BALL HEADS: MECTACER 01.29.231H HEAD BIOLOX OPTION Ø 32 (K131518) LOT 2315674: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUL-2023. EXPIRATION DATE: 2028-06-12. 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 01.29.240A SLEEVE SIZE S (K131518) LOT 2305476: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2023. EXPIRATION DATE: 2028-03-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW. LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT 2306397: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-MAY-2023. EXPIRATION DATE: 2028-04-11. 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 3D METAL 01.38.350MH ACETABULAR SHELL Ø50 MULTI-HOLE THIN (K202568) LOT 2207371: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUN-2022. EXPIRATION DATE: 2027-06-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

    AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED ALL COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    383356 STEM: QUADRA-P COLLARED STD STEM SIZE 4 HIP STEM LZO MEDACTA INTERNATIONAL SA 2249416 07630040731881

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Female Required Intervention