BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_COCR FEMORAL HEAD

    MDR report key: 10294555 · Received July 20, 2020

    Report

    Report Number
    0002249697-2020-01478
    Event Type
    Injury
    Date Received
    July 20, 2020
    Date of Event
    January 1, 2012
    Report Date
    July 20, 2020
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JDI
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICE IS NOT AVAILABLE FOR EVALUATION. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, IT WILL BE PROVIDED IN A SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Description of Event or Problem · 1

    IN A JOURNAL OF ARTHROPLASTY ARTICLE (ISSUE 33 (2018) 931-938), "FRETTING AND CORROSION DAMAGE IN RETRIEVED METAL-ON-POLYETHYLENE MODULAR TOTAL HIP ARTHROPLASTY SYSTEMS: WHAT IS THE IMPORTANCE OF FEMORAL HEAD SIZE?", A STUDY OF 92 STEMS IS REPORTED. OF THE 92 STEMS, 41 ARE IDENTIFIED AS STRYKER STEMS (13 "PCA E-SERIES"; 6 "PCA TEXTURED"; 6 "CITATION TMZF"; 3 "PCA"; 2 EACH OF "SECUR-FIT MAX", "RESTORATION HA", "ACCOLADE"; 2 "HNR"; 1 EACH OF "OMNIFIT", "RESTORATION MODULAR", "DEFINITION", "V40 TEXTURED, "MERIDIAN"). ALL STEMS (STRYKER AND COMPETITOR) ARE REPORTED TO HAVE BEEN IMPLANTED WITH COCR FEMORAL HEADS OF SEVERAL SIZE AND OFFSET COMBINATIONS. THE REASONS FOR REVISION ARE REPORTED (AS "CONFIRMED OR SUSPECTED INFECTION (32), ASEPTIC LOOSENING (27), UNSPECIFIED CLINICAL FAILURE (18), INSTABILITY (6), PERIPROSTHETIC FRACTURE (5), AND UNKNOWN REASON (4)"). FRETTING AND CORROSION WERE DIVIDED INTO FOUR GRADES, INCLUDING "NONE (GRADE 1)." NO REASONS FOR REVISION WERE LINKED TO ANY SPECIFIC STEM. NO DEGREE OF FRETTING OR CORROSION WAS LINKED TO ANY SPECIFIC STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    763117 UNKNOWN_COCR FEMORAL HEAD PROSTHESIS, HIP, SEMI-CONSTRAINED, METAL/POLYMER, CEMENTED JDI STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R