BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN HIP FEMORAL STEM

    MDR report key: 11731853 · Received April 27, 2021

    Report

    Report Number
    1818910-2021-08860
    Event Type
    Injury
    Date Received
    April 27, 2021
    Date of Event
    October 29, 2019
    Report Date
    April 12, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT #: (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR MANUFACTURING RECORD EVALUATION, WAS NOT POSSIBLE AS THE REQUIRED LOT NUMBER WAS NOT PROVIDED. THE INFORMATION RECEIVED WILL BE RETAINED FOR TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT RECEIVED A HIP IMPLANT ON DATE (B)(6) 2010. THE DEVICES HAVE RESULTED DEFECTIVE. THE PATIENT WAS "RECALLED" BY THE HEALTH FACILITY FOR CHECK AND HIGH CR-CO IONS LEVELS WERE FOUND (7.66 MICROG./L OF CR AND 11.34 MICROG/L OF CO). PATIENT HAD ALSO PAIN. DOI: (B)(6) 2010: DOR: (B)(6) 2019: HIP UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    628973 UNKNOWN HIP FEMORAL STEM HIP FEMORAL STEM KWA DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention UNK HIP ACETABULAR CUP ASR| UNK HIP FEMORAL HEAD METAL ASR| UNK HIP FEMORAL SLEEVE ASR