BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4

    MDR report key: 14367131 · Received May 12, 2022

    Report

    Report Number
    3005180920-2022-00360
    Event Type
    Injury
    Date Received
    May 12, 2022
    Date of Event
    April 12, 2022
    Report Date
    May 12, 2022
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LZO
    UDI-DI
    07630030809217
    PMA / PMN Number
    K112115
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    BATCH REVIEW PERFORMED ON 14 APRIL 2022. LOT 2100273: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2021. EXPIRATION DATE: 2026-APR-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH 1 SIMILAR REPORTED EVENT. ADDITIONAL DEVICES INVOLVED: BATCH REVIEW PERFORMED ON 14 APRIL 2022. STEM: AMISTEM-P COLLARED 01.18.432 AMISTEM-P COLLARED STD STEM SIZE 2 (K173794) LOT 2106915: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2021. EXPIRATION DATE: 2026-SEP-16. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. CUP: MPACT 01.32.154SH ACETABULAR SHELL Ø54 NO-HOLE (K132879) LOT 1906188: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 02-OCT-2019. EXPIRATION DATE: 2024-SEP-22. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT. LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 2109540: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 20-AUG-2021. EXPIRATION DATE: 2026-JUL-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT.

    Description of Event or Problem · 0

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT 3 MONTHS AND A HALF AFTER THE PRIMARY SURGERY, 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
    2132080 MECTACER BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 36 SIZE L + 4 HIP CERAMIC HEAD LZO MEDACTA INTERNATIONAL SA 01.29.210 2100273 07630030809217

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention