BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L

    MDR report key: 10486816 · Received September 3, 2020

    Report

    Report Number
    3005180920-2020-00577
    Event Type
    Injury
    Date Received
    September 3, 2020
    Date of Event
    August 5, 2020
    Report Date
    September 3, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT: LOT 176826: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-FEB-2018. EXPIRATION DATE: 2023-02-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED BY MEDACTA REGULATORY AFFAIRS DEPARTMENT: STEM: AMISTEM-P COLLARED 01.18.430 AMISTEM-P COLLARED STD STEM SIZE 0 (K173794) LOT 1810257: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-FEB-2019. EXPIRATION DATE: 2024-01-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE,(B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3239 HCT FLAT PE HC LINER Ø32/C (K103721) LOT 1810215: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-DEC-2018. EXPIRATION DATE: 2023-11-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 OTHER SIMILAR REPORTED EVENT. CUP: MPACT 01.32.148DH ACETABULAR SHELL Ø48 TWO-HOLES (K132879) LOT 1811186: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2019. EXPIRATION DATE: 2024-04-01. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH 1 OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN AFTER 1 YEAR FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. 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
    951613 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L HIP CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.206 176826 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention