BEUDAMED
    FDA Adverse Event Injury Summary report: N

    QUADRA-H CEMENTLESS, HA COATED STEM 1 LAT

    MDR report key: 6112786 · Received November 18, 2016

    Report

    Report Number
    3005180920-2016-00601
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    March 9, 2016
    Report Date
    November 18, 2016
    Manufacturer
    MEDACTA INTERNATIONAL SA
    Product Code
    JDI
    PMA / PMN Number
    K082792
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE CASE WAS INITIALLY ASSOCIATED TO THE ACETABULAR COMPONENTS ONLY, NOT MARKETED IN THE USA . UPON RECEIPT OF FOLLOW-UP INFORMATION ABOUT THE REVISION SURGERY AND THE EXPLANTED COMPONENTS, ON 20 OCTOBER 2016 THIS CASE WAS RE-ASSESSED AND ASSOCIATED TO THE STEM COMPONENT (STEM LOOSENING), MARKETED IN THE USA, AND THE CASE WAS THEN CONSIDERED TO BE REPORTED. THE (B)(4) PERFORMED A CLINICAL EVALUATION AND COMMENTED AS FOLLOWS: CEMENTLESS THA ON A FEMALE PATIENT IN 2009, WHEN SHE WAS (B)(6). THE PATIENT PROBABLY HAD SOME DEGREE OF ROTATIONAL DEFORMITY, JUDGING FORM THE SINGLE-PROJECTION POSTOPERATIVE X-RAY, WHICH MAY HAVE CAUSED AN UNDERSIZED FEMORAL STEM TO BE CHOSEN. AFTER 7 YEARS, SOME WEAR OF THE PE INSERT IS VISIBLE, AND IT MAY HAVE ORIGINATED THE BEGINNING OSTEOLYSIS VISIBLE AT FEMORAL LEVEL, ALTHOUGH NOT VERY LARGE. PROGRESSIVE CORTICAL THINNING, AS IS PHYSIOLOGICAL WITH AGING, MAY HAVE CONTRIBUTED, ALONG WITH GRANULOMATOSIS, TO THE ASEPTIC MOBILIZATION OF THE SMALL FEMORAL STEM. BATCH REVIEW PERFORMED ON 07 NOVEMBER . LOT 082245: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 19 SEPTEMBER 2008. EXPIRATION DATE 2013-08-31. 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

    REVISION SURGERY AFTER 6 YEARS AND 11 MONTHS DUE TO STEM LOOSENING. THERE WAS A LEG LENGTH DISCREPANCY OF 2.5 CM AND DECENTRALIZATION OF THE HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765760 QUADRA-H CEMENTLESS, HA COATED STEM 1 LAT CEMENTLESS FEMORAL STEM JDI MEDACTA INTERNATIONAL SA 082245

    Patients

    Seq Age Sex Outcome Treatment
    1 73 YR Required Intervention