BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES

    MDR report key: 10612283 · Received October 1, 2020

    Report

    Report Number
    3005180920-2020-00666
    Event Type
    Injury
    Date Received
    October 1, 2020
    Date of Event
    June 22, 2020
    Report Date
    October 1, 2020
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    LPH
    UDI-DI
    07630030810763
    PMA / PMN Number
    K132879
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 10 SEPTEMBER 2020: LOT 1902268: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-JULY-2019. EXPIRATION DATE: 2024-07-06. 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. ADDITIONAL IMPLANT INVOLVED: LINER: MPACT 01.32.3241HCT FLAT PE HC LINER Ø32/D (K103721) LOT. 187906. BATCH REVIEW PERFORMED ON 10 SEPTEMBER 2020: LOT 187906: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 21-NOV-2018. EXPIRATION DATE: 2023-11-07. 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. ADDITIONAL IMPLANT INVOLVED: STEM: AMISTEM H 01.18.134 HA COATED STD STEM SIZE 4 (K093944) LOT. 173437. BATCH REVIEW PERFORMED ON 10 SEPTEMBER 2020: LOT 173437: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-SEPT-2017. EXPIRATION DATE: 2022-08-22. 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

    6 MONTHS AFTER PRIMARY REVISION SURGERY PERFORMED DUE TO INFECTION. LEFT SIDE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1078447 CUP: MPACT ACETABULAR SHELL 50 TWO-HOLES ACETABULAR SHELL LPH MEDACTA INTERNATIONAL SA 01.32.150DH 1902268 07630030810763

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Required Intervention