BEUDAMED
    FDA Adverse Event Injury Summary report: N

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

    MDR report key: 10763173 · Received October 30, 2020

    Report

    Report Number
    3005180920-2020-00768
    Event Type
    Injury
    Date Received
    October 30, 2020
    Date of Event
    October 3, 2020
    Report Date
    October 30, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809170
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 13 OCTOBER 2020: LOT 1905643: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-SEP-2019. EXPIRATION DATE: 2024-09-15. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT: CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES LOT. 1908321 (K132879). BATCH REVIEW PERFORMED ON 13 OCTOBER 2020: LOT 1908321: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-DEC-2019. EXPIRATION DATE: 2024-12-02. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ONE SIMILAR EVENT REPORTED. LINER: MPACT 01.32.3244HCT FLAT PE HC LINER Ø32/E LOT. 1910286 (K103721). BATCH REVIEW PERFORMED ON 13 OCTOBER 2020: LOT 1910286: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-DEC-2019. EXPIRATION DATE: 2024-12-04. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN, 1 MONTH AFTER PRIMARY SURGERY, DUE TO SIGNS OF INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, LINER, AND CUP. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1229707 BALL HEADS: MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 32 SIZE L CERAMIC BALL HEAD LZO MEDACTA INTERNATIONAL SA 01.29.206 1905643 07630030809170

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention