BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PERSONA CEMENTED STEMMED TIBIAL COMPONENT

    MDR report key: 5198876 · Received November 3, 2015

    Report

    Report Number
    1822565-2015-02283
    Event Type
    Injury
    Date Received
    November 3, 2015
    Report Date
    May 12, 2017
    Manufacturer
    ZIMMER INC
    Product Code
    JWH
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    INFORMATION IN THIS REPORT WAS PREVIOUSLY SUBMITTED UNDER 0001822565-2015-02283-1. SURGICAL NOTES PROVIDED DO NOT INDICATE THAT ANY ANOMALIES OR DEVIATIONS OCCURED DURING THE PROCEDURE. NO GROSS ISSUES COULD BE SEEN IN THE X-RAYS OR THE SURGICAL NOTES THAT WOULD PROVIDE INSIGHT FOR THE PATIENT¿S PAIN. A COMPLAINT HISTORY SEARCH WAS CONDUCTED AND FOUND NO NEW COMPLAINTS FOR THE RELATED PART/LOT NUMBERS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG #42540000032, PERSONA ALL POLY PATELLA, LOT #62402287; CATALOG #42521400510, PERSONA PS ARTICULAR SURFACE, LOT #62831942; CATALOG #42500006402, PERSONA PS CEMENTED FEMORAL COMPONENT, LOT #62839976 - MANUFACTURED BY ZIMMER (B)(4). THESE DEVICES ARE USED FOR TREATMENT. SURGICAL NOTES WERE NOT PROVIDED; IT IS UNKNOWN WHETHER THE COMPONENTS WERE IMPLANTED WITH THE CORRECT FIT AND ORIENTATION AS PER THE SURGICAL TECHNIQUE. A PRODUCT HISTORY SEARCH REVEALED NO ADDITIONAL COMPLAINTS AGAINST THE RELATED PART AND LOT COMBINATIONS. A DEFINITIVE ROOT CAUSE CANNOT BE DETERMINED WITH THE INFORMATION PROVIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT IS EXPERIENCING PAIN, IS UNABLE TO CLIMB STAIRS AND REQUIRES THE USE OF A CANE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    729761 PERSONA CEMENTED STEMMED TIBIAL COMPONENT JWH JWH ZIMMER INC 62910950

    Patients

    Seq Age Sex Outcome Treatment
    1 Other