BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TRIATHLON ASYM PATELLA A40X11

    MDR report key: 4241412 · Received November 10, 2014

    Report

    Report Number
    0002249697-2014-04214
    Event Type
    Injury
    Date Received
    November 10, 2014
    Date of Event
    October 16, 2014
    Report Date
    October 16, 2014
    Manufacturer
    STRYKER ORTHOPAEDICS-MAHWAH
    Product Code
    JWH
    PMA / PMN Number
    K040267
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, 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. NOT AVAILABLE.

    Additional Manufacturer Narrative · 1

    CORRECTED UNIT OF WEIGHT BASED ON ADDITIONAL INFORMATION. AN EVENT REGARDING PATELLAR DISLOCATION INVOLVING A TRIATHLON PATELLAR COMPONENT WAS REPORTED. THE EVENT WAS CONFIRMED. MEDICAL RECORDS RECEIVED AND EVALUATION: MALPOSITION OF THE TIBIAL COMPONENT WAS LIKELY RESPONSIBLE FOR THE CHRONIC DISLOCATION OF THE RIGHT PATELLA IN THIS CASE. THERE IS NO EVIDENCE OF FACTORS OF FAULTY COMPONENT DESIGN, MANUFACTURING, OR MATERIALS AS BEING RESPONSIBLE FOR THIS CLINICAL SITUATION. DEVICE HISTORY REVIEW: INDICATED THAT ALL DEVICES ACCEPTED INTO FINAL STOCK MET SPECIFICATION. COMPLAINT HISTORY REVIEW: INDICATED THAT THERE HAVE NOT BEEN ANY OTHER EVENTS FOR THE SPECIFIED LOT. CONCLUSIONS: THE MEDICAL REVIEW OF THE PROVIDED INFORMATION INDICATED THAT MALPOSITION OF THE TIBIAL COMPONENT WAS LIKELY RESPONSIBLE FOR THE CHRONIC DISLOCATION OF THE RIGHT PATELLA IN THIS CASE.

    Description of Event or Problem · 1

    PATIENT HAD TKA ON (B)(6) 2006, TWO MONTHS POST OP PATIENT FELL WHILE DOING PHYSICAL THERAPY, TORE HIS RETINACULAR REPAIR. TAKEN BACK FOR REPAIR OF THE SOFT TISSUE ONLY. APPROXIMATELY 2 YEARS AGO STARTED HAVING PAIN. FOUND PATELLA WAS LATERALLY DISPLACED. SURGEON ELECTED TO REPLACE ALL IMPLANTS.

    Description of Event or Problem · 1

    PATIENT HAD TKA ON (B)(6) 2006, TWO MONTHS POST OP PATIENT FELL WHILE DOING PHYSICAL THERAPY, TORE HIS RETINACULAR REPAIR. TAKEN BACK FOR REPAIR OF THE SOFT TISSUE ONLY. APPROXIMATELY 2 YEARS AGO STARTED HAVING PAIN. FOUND PATELLA WAS LATERALLY DISPLACED. SURGEON ELECTED TO REPLACE ALL IMPLANTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    722659 TRIATHLON ASYM PATELLA A40X11 IMPLANT JWH STRYKER ORTHOPAEDICS-MAHWAH LN944

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Hospitalization| R