BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2

    MDR report key: 7522298 · Received May 17, 2018

    Report

    Report Number
    3005180920-2018-00339
    Event Type
    Injury
    Date Received
    May 17, 2018
    Date of Event
    April 18, 2018
    Report Date
    May 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
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    BATCH REVIEW PERFORMED ON 17 MAY 2018; LOT 072776: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05 DECEMBER 2007. EXPIRATION DATE: 2012-10-31; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. OTHER DEVICE INVOLVED LINER: CC E CC LIGHT FLAT PE LINER Ø 28 / E REFERENCE 01.26.2844STT (K103352); LOT 060220: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18 APRIL 2006. EXPIRATION DATE: 2011-02-28; NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT. CLINICAL EVALUATION PERFORMED BY MEDICAL AFFAIRS MANAGER: PARTIAL HIP REVISION SURGERY (STEM, HEAD AND LINER) OCCURRED 10 YEARS AFTER PRIMARY CEMENTLESS TOTAL HIP ARTHROPLASTY. RADIOGRAPHIC IMAGE PROVIDED SHOWS THE PRESENCE OF LOCALIZED OSTEOLYTIC LESIONS AROUND THE STEM THAT LOOKS SLIGHTLY VARUS. POLYETHYLENE WEAR IS A COMMON LONG-TERM FINDING, DESCRIBED AND QUANTIFIED IN LITERATURE, WHEN STANDARD POLYETHYLENE LINERS ARE USEDAND AND IT COULD BE A POSSIBLE CAUSE OF THIS EVENT.

    Description of Event or Problem · 1

    ON (B)(6) 2018 WE WERE INFORMED THAT THE SURGEON WILL REVISE ON (B)(6) A PATIENT DUE TO STEM LOOSENING AND INSERT SUSPECTED WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    365018 QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 2 CEMENTLESS HIP STEM JDI MEDACTA INTERNATIONAL SA 072776 07630030802034

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention