BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: VERSACEM DOUBLE MOBILITY HC LINER 56/28

    MDR report key: 12405771 · Received September 1, 2021

    Report

    Report Number
    3005180920-2021-00690
    Event Type
    Injury
    Date Received
    September 1, 2021
    Date of Event
    August 3, 2021
    Report Date
    September 1, 2021
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807411
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 04.AUG.2021: LOT 2009655: 120 ITEMS MANUFACTURED AND RELEASED ON 4-NOV-2020. EXPIRATION DATE: 2025-10-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 77 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. ADDITIONAL ITEMS INVOLVED IN THE EVENT, BATCH REVIEW PERFORMED ON 04.AUG.2021: CUP: VERSACEM 01.27.56CMB DOUBLE MOBILITY METAL BACK CEMENTED 56 LOT. 1900897 (ITEM NOT REGISTERED IN USA). LOT 1900897: 19 ITEMS MANUFACTURED AND RELEASED ON 23-MAY-2019. EXPIRATION DATE: 2024-05-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 10 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT A SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.202 BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE M 0 LOT. UNKNOWN (K112115).

    Description of Event or Problem · 1

    2 MONTHS AFTER THE PRIMARY SURGERY THE SURGEON REMOVED THE IMPLANTS DUE TO INFECTION. THE CUP, LINER AND HEAD WERE MEDACTA WHILE THE STEM WAS A COMPETITOR PRODUCT. THE BALL HEAD LOT IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1307465 LINER: VERSACEM DOUBLE MOBILITY HC LINER 56/28 CEMENTLESS STEM MEH MEDACTA INTERNATIONAL SA 01.26.2856MHC 2009655 07630030807411

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention