BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN_RECONSTRUCTIVE_PRODUCT

    MDR report key: 3002505 · Received March 13, 2013

    Report

    Report Number
    0002249697-2013-00971
    Event Type
    Injury
    Date Received
    March 13, 2013
    Date of Event
    February 27, 2013
    Report Date
    February 27, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ALL RECORDS WERE REVIEWED BY A CONSULTING CLINICIAN WHO INDICATED INSUFFICIENT MEDICAL INFORMATION WAS PROVIDED FOR REVIEW. THE EVENT WAS NOT CONFIRMED. DEVICE HISTORY REVIEW AND COMPLAINT HISTORY REVIEW NOT PERFORMED AS NO DEVICE INFORMATION WAS PROVIDED FOR REVIEW. THE EXACT CAUSE OF THE EVENT COULD NOT BE DUE TO LIMITED MEDICAL RECORDS AND NO DEVICE INFORMATION.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN POLY INSERT. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT. NOT RETURNED TO MANUFACTURER.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP GOT A CALL FROM COMPETITOR DOCTOR REQUESTING POLY INSERTS FOR A POLY SWAP OF THE RIGHT TOTAL KNEE. THE PATIENT WAS COMPLAINING OF PAIN AND HAD A TRIATHLON KNEE WITH POSTERIOR STABILIZER POLY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE SALES REP GOT A CALL FROM COMPETITOR DOCTOR REQUESTING POLY INSERTS FOR A POLY SWAP OF THE RIGHT TOTAL KNEE. THE PATIENT WAS COMPLAINING OF PAIN AND HAD A TRIATHALON KNEE WITH POSTERIOR STABILIZER POLY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    105526 UNKNOWN_RECONSTRUCTIVE_PRODUCT IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR Required Intervention