BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF

    MDR report key: 8482793 · Received April 4, 2019

    Report

    Report Number
    3005180920-2019-00230
    Event Type
    Injury
    Date Received
    April 4, 2019
    Date of Event
    March 5, 2019
    Report Date
    June 5, 2019
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    MEH
    UDI-DI
    07630030807343
    PMA / PMN Number
    K092265
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    IN THE INITIAL REPORT THE FOLLOWING BATCH RECORD REVIEWS (ALREADY PERFORMED AT THAT DAY) WERE NOT INCLUDED BY MISTAKE: BATCH REVIEW PERFORMED ON 01 APRIL 2019: STEM: MINIMAX 01.13.103R CEMENTLESS ANATOMICAL STEM RIGHT SIZE 3 (K170845), LOT 166126A: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-JUL-2018. EXPIRATION DATE: 2023-07-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ANOTHER ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT SIMILAR REPORTED EVENT. BALL HEADS: MECTACER 01.29.201 BIOLOX DELTA CERAMIC BALL HEAD 12/14 Ø 28 SIZE S -3.5 (K112115), LOT 179038: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2018. EXPIRATION DATE: 2023-05-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEM OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 01 APRIL 2019: LOT 184725: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-SEP-2018. EXPIRATION DATE: 2023-08-19. 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

    REVISION SURGERY PERFORMED 3 MONTHS FROM THE PRIMARY DUE TO SIGNS OF INFECTION (THE PATHOGEN IS UNKNOWN). THE SURGEON PERFORMED A WASHOUT AND REVISED THE HEAD, STEM AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    276773 LINER: MPACT DM DOUBLE MOBILITY HC LINER 28/DMF DOUBLE MOBILITY HC ACETABULAR LINER MEH MEDACTA INTERNATIONAL SA 184725 07630030807343

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention