BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SECUR-FIT MAX 132 HIP STEM #6

    MDR report key: 3023673 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01093
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    March 4, 2013
    Report Date
    March 4, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    PMA / PMN Number
    K051738
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING A REVISION DUE TO DYSPLASTIC FORMATION OF BONE AT THE ISTHMUS INVOLVING A SECUR-FIT MAX 132 HIP STEM #6 WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW: ALL DEVICES ACCEPTED INTO FINISHED GOODS CONFORMED TO SPECIFICATION. COMPLAINT HISTORY REVIEW: NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODE WAS IDENTIFIED. IT WAS REPORTED THAT THE DOCTOR REVISED AS IT WAS THOUGHT THAT THE STEM WAS LOOSE. IT WAS DETERMINED THAT THE PATIENT HAD A DYSPLASTIC FORMATION OF BONE AT THE ISTHMUS.

    Additional Manufacturer Narrative · 1

    AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR REVISED HIP STEM DUE TO DYSPLASTIC FORMATION OF BONE AT THE ISTHMUS. HE THOUGHT IT MIGHT BE LOOSE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE DOCTOR REVISED HIP STEM DUE TO DYSPLASTIC FORMATION OF BONE AT THE ISTHMUS. HE THOUGHT IT MIGHT BE LOOSE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    126965 SECUR-FIT MAX 132 HIP STEM #6 IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH 33955403

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention