BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MPACT ACETABULAR SHELL 52 TWO-HOLES

    MDR report key: 10613014 · Received October 1, 2020

    Report

    Report Number
    3005180920-2020-00661
    Event Type
    Malfunction
    Date Received
    October 1, 2020
    Date of Event
    December 11, 2018
    Report Date
    October 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810794
    PMA / PMN Number
    K132879
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON (B)(6) 2020: LOT 184592: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-OCT-2018. EXPIRATION DATE: 2023-10-08. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 98 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT. ADDITIONAL DEVICE INVOLVED: BATCH REVIEW PERFORMED ON (B)(6) 2020: LINER: MPACT 01.32.3644HCT FLAT PE HC LINER Ø36/E (K103721) LOT 185987: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 25-SEP-2018. EXPIRATION DATE: 2023-09-10. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 108 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.

    Description of Event or Problem · 1

    REVISION SURGERY PERFORMED, 1 DAY AFTER PRIMARY SURGERY, DUE TO DISSOCIATION OF THE LINER FROM THE CUP. RIGHT SIDE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1076598 MPACT ACETABULAR SHELL 52 TWO-HOLES HIP UNCEMENTED SHELL LPH MEDACTA INTERNATIONAL SA 01.32.152DH 184592 07630030810794

    Patients

    Seq Age Sex Outcome Treatment
    1 78 YR Required Intervention