BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 2931393 · Received January 28, 2013

    Report

    Report Number
    0002249697-2013-00362
    Event Type
    Injury
    Date Received
    January 28, 2013
    Date of Event
    January 14, 2013
    Report Date
    January 14, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    MEH
    PMA / PMN Number
    UNK
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    A REVIEW OF THE DEVICE HISTORY RECORDS INDICATES THAT THE REPORTED DEVICES WERE MANUFACTURED AND ACCEPTED INTO FINAL STOCK WITH NO REPORTED DISCREPANCIES. THE COMPLAINT HISTORY REVIEW INDICATED THAT THERE WERE NO SIMILAR EVENTS FOR THE REPORTED LOT. A MATERIAL ANALYSIS WAS PERFORMED ON THE RETURNED DEVICE. THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS THE PROVIDED MEDICAL INFORMATION WAS REVIEWED BY A CONSULTING CLINICIAN WHO CONCLUDED THAT THE REPORTED EVENT APPEARS UNRELATED TO FACTORS OF PROSTHETIC MANUFACTURING OR MATERIALS. THE INVESTIGATION CONCLUDED THAT JOINT INSTABILITY WAS CAUSED BY POLY WEAR, BUT THERE WAS NO EVIDENCE OF MANUFACTURING OR MATERIAL DEFECTS.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN 72-3 #3X10MM PS TIBIAL INSERT. WHEN COMPLETED, THE EVALUATION SUMMARY WILL BE SUBMITTED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING KNEE PAIN AND INSTABILITY. EXCHANGED 3X10MM PS INSERT FOR A 3X18MM PS FLEX TIBIAL INSERT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING KNEE PAIN AND INSTABILITY. EXCHANGED 3X10MM PS INSERT FOR A 3X18MM PS FLEX TIBIAL INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    37020 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT MEH STRYKER ORTHOPAEDICS-MAHWAH UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 62 YR Required Intervention