BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60

    MDR report key: 9826671 · Received March 12, 2020

    Report

    Report Number
    3005180920-2020-00142
    Event Type
    Injury
    Date Received
    March 12, 2020
    Date of Event
    February 11, 2020
    Report Date
    March 12, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030861017
    PMA / PMN Number
    K143453
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 11-MAR-2020 LOT 185439: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-OCT-2018. EXPIRATION DATE: 14.10.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. OTHER DEVICES INVOLVED IN THE EVENT BALL HEADS: MECTACER 01.29.203 BIOLOX DELTA CERAMIC BALL HEAD 12/14 28 SIZE L +3.5 LOT. 1903848 (K112115) BATCH REVIEW PERFORMED ON 11-MAR-2020: LOT 1903848: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-JUL-2019. EXPIRATION DATE: 14.07.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT. STEM: AMISTEM P 01.18.438 AMISTEM-P COLLARED STD STEM SIZE8 LOT. 178151 (K173794) BATCH REVIEW PERFORMED ON 11-MAR-2020 LOT 178151: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-APR-2018. EXPIRATION DATE: 27.03.2023. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT. LINER: MPACT DM 01.26.2860MHC DOUBLE MOBILITY HC LINER 28/DML LOT. 1901460 (K092265) LOT 1901460: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAY-2019. EXPIRATION DATE: 28.04.2024. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AFTER ALMOST 1 MONTH FROM THE PRIMARY SURGERY, THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    290547 CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø60 DOUBLE MOBILITY ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.160MB 185439 07630030861017

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention