BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MODULAR POLYCENTRIC EBS KNEE JOINT K/D

    MDR report key: 9817148 · Received March 11, 2020

    Report

    Report Number
    9616494-2018-00060
    Event Type
    Malfunction
    Date Received
    March 11, 2020
    Report Date
    April 13, 2018
    Manufacturer
    OTTO BOCK HEALTHCARE GMBH
    Product Code
    ISY
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE VISUAL EVALUATION SHOWED THAT TWO OF THE UPPER BOLTS WERE LOOSE. THE PATIENT FELL BUT THERE WERE NO SERIOUS INJURIES SUSTAINED AS A RESULT OF THE FALL. NO MEDICAL TREATMENT WAS NEEDED.

    Description of Event or Problem · 1

    KNEE JOINT WAS SENT IN FOR REPAIR. ACCORDING TO INFORMATION PROVIDED BY THE CUSTOMER THE BOLTS WERE LOOSE. PATIENT FELL, BUT THERE WERE NO SERIOUS INJURIES SUSTAINED AS A RESULT OF THE FALL. NO MEDICAL TREATMENT WAS NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    280940 MODULAR POLYCENTRIC EBS KNEE JOINT K/D MODULAR POLYCENTRIC EBS KNEE JOINT K/D ISY OTTO BOCK HEALTHCARE GMBH 3R60=KD

    Patients

    Seq Age Sex Outcome Treatment
    1 47 YR