BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON ASYMMETRIC X3 PATELLA

    MDR report key: 3140708 · Received May 31, 2013

    Report

    Report Number
    0002249697-2013-01835
    Event Type
    Injury
    Date Received
    May 31, 2013
    Date of Event
    January 20, 2012
    Report Date
    May 9, 2013
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K051146
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    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. PATIENT MEDICAL RECORDS WERE PROVIDED FOR REVIEW BY A CONSULTING CLINICIAN WHO INDICATED THAT THERE IS NO EVIDENCE THAT FACTORS OF FAULTY PROSTHETIC DESIGN, MANUFACTURING, OR MATERIALS ARE RESPONSIBLE FOR HER CLINICAL SITUATION. THE EVENT COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. THE EXACT ROOT CAUSE OF THE EVENT COULD NOT BE DETERMINED DUE; HOWEVER, WITH THE INFORMATION PROVIDED, IT IS LIKELY THAT THIS EVENT IS NOT DEVICE RELATED. CATALOG NUMBERS AND LOT CODES OF OTHER DEVICES LISTED IN THIS REPORT: CAT # 5515-F-402, LOT # GGRH, DESCRIPTION: TRIATHLON PS FEM COMPONENT - CEMENTED; CAT # 5520-B-400, LOT # GOZA, DESCRIPTION: TRIATHLON PRIM TIB BASEPLATE - CEMENTED CAT # 5532-G-409 , LOT # MKRVA4, DESCRIPTION: TRIATHLON PS X3 TIBIAL INSERT.

    Additional Manufacturer Narrative · 1

    CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT TRIATHLON KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE PROVIDED IN A SUPPLEMENTAL REPORT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING PAIN SINCE SURGERY ON HER RIGHT KNEE IN 2012. PATIENT STATES THAT HER KNEE MAKES A CLICKING NOISE AND THAT THE KNEE FEELS LOOSE AND VERY UNSTABLE. PATIENT REPORTS THAT SHE HAD BEEN TOLD TO REMAIN ON BED REST. PATIENT ALSO STATES THAT WHEN SHE DOES WALK SHE USES A CANE OR CRUTCHES.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT HAS BEEN EXPERIENCING PAIN SINCE SURGERY ON HER RIGHT KNEE IN 2012. PATIENT STATES THAT HER KNEE MAKES A CLICKING NOISE AND THAT THE KNEE FEELS LOOSE AND VERY UNSTABLE. PATIENT REPORTS THAT SHE HAD BEEN TOLD TO REMAIN ON BED REST. PATIENT ALSO STATES THAT WHEN SHE DOES WALK SHE USES A CANE OR CRUTCHES.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    241934 TRIATHLON ASYMMETRIC X3 PATELLA IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH 25DN

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other