BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0

    MDR report key: 14021284 · Received April 6, 2022

    Report

    Report Number
    3005180920-2022-00230
    Event Type
    Injury
    Date Received
    April 6, 2022
    Date of Event
    March 8, 2022
    Report Date
    June 4, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809200
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 05 APRIL 2022: LOT 2105988: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 09-SEP-2021. EXPIRATION DATE: 2026-08-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEWS PERFORMED ON 05 APRIL 2022: STEM: AMISTEM P 01.18.433 AMISTEM-P COLLARED STD STEM SIZE 3 (K173794) LOT 2109757: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-NOV-2021. EXPIRATION DATE: 2026-10-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CUP: MPACT 01.32.152DH ACETABULAR SHELL Ø52 TWO-HOLES (K132879) LOT 2106952: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2021. EXPIRATION DATE: 2026-09-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2109539: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-SEP-2021. EXPIRATION DATE: 2026-08-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    AT 1 MONTH 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 IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1440479 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE M 0 HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.209 2105988 07630030809200

    Patients

    Seq Age Sex Outcome Treatment
    1 Female Required Intervention