BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIDENT 0 DEG INSERT 40MM

    MDR report key: 2915550 · Received January 10, 2013

    Report

    Report Number
    2249697-2013-90110
    Event Type
    Injury
    Date Received
    January 10, 2013
    Date of Event
    December 18, 2012
    Report Date
    December 18, 2012
    Manufacturer
    STRYKER ORTHOPAEDICS MAHWAH
    Product Code
    LPH
    PMA / PMN Number
    K061434
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: PRIMARY TRITANIUM HEMI SOLIDBACK CUP 60MM, CAT# 500-03-60F, CAT# MLM65L. V40 COCR LFIT HEAD 40MM/+0, CAT# 6260-9-140, LOT# MKLHXK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PT'S DISLOCATION. ADDITIONAL INFO (INCLUDING X-RAYS AND MEDICAL RECORDS) WAS REQUESTED. WHEN COMPLETED, THE EVAL SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT IS REPORTED THAT: SURGEON REVISED PT'S RIGHT HIP BECAUSE OF REPEATED DISLOCATIONS. SURGEON REMOVED THE CUP, LINER, AND HEAD AND REPLACED WITH BIGGER CUP, MDM LINER, AND MDM HEAD.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    15162 TRIDENT 0 DEG INSERT 40MM IMPLANT LPH STRYKER ORTHOPAEDICS MAHWAH NA MKNEKA

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention