BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3203211 · Received July 2, 2013

    Report

    Report Number
    0002249697-2013-02207
    Event Type
    Injury
    Date Received
    July 2, 2013
    Date of Event
    June 7, 2013
    Report Date
    June 7, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN, THE DEVICE WAS REPORTED AS AN UNKNOWN 28M POLY INSERT. EVALUATION SUMMARY: AN X-RAY WAS PROVIDED TO A CONSULTING CLINICIAN WHO REJECTED IT FOR REVIEW AS INSUFFICIENT INFORMATION WAS PROVIDED, HOWEVER, THE X-RAY DID CONFIRM POLY WEAR BUT WAS NOT ENOUGH TO JUSTIFY A REVISION. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE TO INSUFFICIENT INFORMATION PROVIDED. THE EXPLANTED DEVICE, PATIENT MEDICAL RECORDS, OPERATIVE REPORTS AND ADDITIONAL X-RAYS WOULD BE REQUIRED FOR FURTHER REVIEW.

    Additional Manufacturer Narrative · 1

    CATALOG NUMBER IS UNKNOWN AT THIS TIME. THE DEVICE WAS REPORTED AS AN UNKNOWN 26MM PCA PAPER HEAD BALL. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT. DEVICE NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEFT HIP REVISION DUE TO POSSIBLE POLY WEAR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THERE WAS A LEFT HIP REVISION DUE TO POSSIBLE POLY WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    302199 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT LPH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention