BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2

    MDR report key: 7793268 · Received August 17, 2018

    Report

    Report Number
    3005180920-2018-00615
    Event Type
    Injury
    Date Received
    August 17, 2018
    Date of Event
    July 19, 2018
    Report Date
    August 17, 2018
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    UDI-DI
    07630030802034
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 AUGUST 2018; LOT 173141: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 SEPTEMBER 2017 EXPIRATION DATE: 2022-09-17; 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. OTHER DEVICES INVOLVED: REFERENCE 25060.2844 (K091967) BIPOLAR HEAD Ø28X44; LOT 175686: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 15 DECEMBER 2017. EXPIRATION DATE:2022-11-30 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. CERAMIC BALL HEAD (NOT MARKETED IN US): NO ANOMALIES FOUND.

    Description of Event or Problem · 1

    THE PATIENT COMPLAINED HIP PAIN 4 MONTHS AFTER PRIMARY SURGERY. THE SURGEON SUSPECTED AN INFECTION AND REMOVED ALL THE IMPLANTS. NEW IMPLANTS FROM COMPETITORS WILL BE IMPLANTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    633413 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 173141 07630030802034

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention