BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3023623 · Received March 27, 2013

    Report

    Report Number
    0002249697-2013-01081
    Event Type
    Injury
    Date Received
    March 27, 2013
    Date of Event
    April 27, 2012
    Report Date
    March 1, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    LZO
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED WITH THE LIMITED INFORMATION AVAILABLE AT THE TIME OF EVALUATION. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME AS NO DEVICES AND/OR INSUFFICIENT INFORMATION WAS RECEIVED BY STRYKER ORTHOPAEDICS. IF DEVICES AND/OR ADDITIONAL INFORMATION BECOME AVAILABLE, THE INVESTIGATION RESULTS WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS X3 POLYETHELYNE 36MM. THE FOLLOWING OTHER HIP DEVICES WERE ALSO LISTED IN THIS REPORT: ACCOLADE II STEM SIZE 5, CAT# UNK, LOT# UNK. TRIDEN CUP 56MM, CAT# UNK, LOT# UNK. CO,CR HEAD 36 +0, CAT# UNK, LOT# UNK. IT CANNOT BE DETERMINED WHICH, IF ANY OF THESE DEVICES MAY HAVE CAUSED OR CONTRIBUTED TO THE PATIENT'S INFECTION. AN EVALUATION OF THE DEVICE CANNOT BE PERFORMED AS THE DEVICE WAS SENT FOR RETRIEVAL ANALYSIS AND WAS NOT RETURNED TO THE MANUFACTURER. MEDICAL RECORDS AND X-RAYS WERE NOT PROVIDED TO STRYKER FOR REVIEW DUE TO REPORTING INSTITUTION IRB AND HIPPA REGULATIONS. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO THE MANUFACTURER.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PERIPROSTHETIC JOINT INFECTION. REVISED IN TWO STAGES.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PERIPROSTHETIC JOINT INFECTION. REVISED IN TWO STAGES.

    Description of Event or Problem · 1

    POSTOPERTIVE DIAGNOSIS: PERIPROSTHETIC JOINT INFECTION. REVISED IN TWO STAGES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125904 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT LZO STRYKER ORTHOPAEDICS-MAHWAH UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 52 YR Required Intervention