BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL

    MDR report key: 17008949 · Received May 26, 2023

    Report

    Report Number
    3005180920-2023-00383
    Event Type
    Injury
    Date Received
    May 26, 2023
    Date of Event
    April 19, 2023
    Report Date
    May 26, 2023
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809224
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 04 MAY 2023: LOT 2117192: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-MAR-2022. EXPIRATION DATE: 2027-03-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH ANOTHER SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. OTHER DEVICES INVOLVED: LINER: MPACT 01.32.3648HCT FLAT PE HC LINER Ø36/F (K103721) LOT 2206484: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2022. EXPIRATION DATE: 2027-04-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. STEM: SMS SOLID 01.36.170 SMS COLLARED SOLID STEM LAT SIZE 10 (K203041) LOT 2206158: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-SEP-2022. EXPIRATION DATE: 2027-09-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW. CUP: MPACT 3D METAL 01.38.056DH ACETABULAR SHELL Ø56 TWO-HOLE (K171966) LOT 2209088: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 01-JULY-2022. EXPIRATION DATE: 2027-05-18. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.

    Description of Event or Problem · 0

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

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1728430 BALL HEADS: MECTACER 01.29.211 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE XL HIP DELTA CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.211 2117192 07630030809224

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention