BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON ASYMMETRIC X3 PATELLA

    MDR report key: 4123280 · Received September 26, 2014

    Report

    Report Number
    0002249697-2014-03629
    Event Type
    Injury
    Date Received
    September 26, 2014
    Date of Event
    April 16, 2013
    Report Date
    September 2, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED, WILL BE PROVIDED IN THE SUPPLEMENTAL REPORT UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    AN EVENT REGARDING REVISION SURGERY INVOLVING A TRIATHLON ASYMMETRIC X3 PATELLA WAS REPORTED. THE EVENT WAS NOT CONFIRMED. DEVICE EVALUATION NOT PERFORMED AS NO ITEMS WERE RECEIVED. MEDICAL EVALUATION NOT PERFORMED AS NO MEDICAL RECORDS WERE RECEIVED. DEVICE HISTORY REVIEW INDICATED ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATIONS. COMPLAINT HISTORY REVIEW NOT PERFORMED AS NO DEVICE SPECIFIC FAILURE MODE WAS REPORTED. THE EXACT CAUSE OF THE EVENT COULD NOT BE DETERMINED BECAUSE NO MEDICAL RECORDS AND OR DEVICE WERE PROVIDED. NO FURTHER INVESTIGATION FOR THIS EVENT IS POSSIBLE AT THIS TIME.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF PATELLAR COMPONENT ON (B)(6) 2014 WHICH WAS ORIGINALLY PLACED (B)(6) 2013.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION OF PATELLAR COMPONENT ON (B)(6) 2014 WHICH WAS ORIGINALLY PLACED ON (B)(6) 2013.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    602721 TRIATHLON ASYMMETRIC X3 PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 3LY5

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Hospitalization| R