BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX

    MDR report key: 2912747 · Received January 7, 2013

    Report

    Report Number
    2249697-2013-90046
    Event Type
    Injury
    Date Received
    January 7, 2013
    Date of Event
    December 11, 2012
    Report Date
    December 11, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K051738
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    IT WAS NOTED THAT THE DEVICES ARE NOT AVAILABLE FOR EVAL. THE PT MEDICAL RECORDS THAT WERE PROVIDED FOR MEDICAL REVIEW WERE INSUFFICIENT TO DETERMINE A POTENTIAL ROOT CAUSE OF THE REPORTED PAIN. CATALOG NUMBERS OF OTHER DEVICES LISTED IN THIS REPORT: DESCRIPTION: ALUMINA C-TAPER HEAD 32MM/0, CAT #17-3200E, LOT #UNK; DESCRIPTION: TRIDENT ALUMINA INSERT, CAT #625-0T-32F, LOT #UNK; DESCRIPTION: TRIDENT PSL HA CLUSTER 56MM. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S EXPERIENCE. ADD'L INFO HAS BEEN REQUESTED BUT NOT PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT PT WAS EXPERIENCING HIP PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    8311 SECUR-FIT MAX IMPLANT LZO STRYKER ORTHOPAEDICS MAHWAH NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other| R