BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT HA PSL SCREWLESS CUP 50MM

    MDR report key: 3283670 · Received August 13, 2013

    Report

    Report Number
    0002249697-2013-02637
    Event Type
    Injury
    Date Received
    August 13, 2013
    Date of Event
    July 18, 2013
    Report Date
    July 18, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    K942900
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: OMNIFIT NORMALIZED HIP STEM: CAT# 6034-0625; LOT# 95L661; C-TAPER COCR LFIT HEAD 26MM/+10: CAT# 06-2610; LOT# 17014001; OMNIFIT SER. II INSERT-10 DEG: CAT# 2041-2650; LOT# 17901801. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S DISLOCATION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS RETAINED BY THE PATIENT AND WAS NOT RETURNED TO THE MANUFACTURER. ADDITIONAL INFORMATION (INCLUDING X-RAYS AND MEDICAL RECORDS) HAS BEEN REQUESTED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A DISLOCATION INVOLVING A SECUR-FIT HA PSL SCREWLESS CUP 50MM WAS REPORTED. IT WAS REPORTED THAT THE PATIENT DISLOCATED. THERE ARE NO ALLEGATIONS AGAINST THE ACETABULAR SHELL. BASED ON THE PROVIDED INFORMATION, THE PRODUCT REPORTED IN THIS INVESTIGATION DID NOT CONTRIBUTE TO THE EVENT.

    Description of Event or Problem · 1

    STEM, HEAD, INSERT, AND CUP WERE REMOVED DUE PATIENT COMPLAINING OF PAIN AND DISLOCATION.

    Description of Event or Problem · 1

    STEM, HEAD, INSERT, & CUP WERE REMOVED DUE PATIENT COMPLAINING OF PAIN AND DISLOCATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    388536 SECUR-FIT HA PSL SCREWLESS CUP 50MM IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH 16907402

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention