BEUDAMED
    FDA Adverse Event Injury Summary report: N

    TI-DBLE LEAD CORT 5.0X80MM SCR IA5.0X80MM

    MDR report key: 12146165 · Received July 9, 2021

    Report

    Report Number
    0001825034-2021-02043
    Event Type
    Injury
    Date Received
    July 9, 2021
    Date of Event
    September 23, 2017
    Report Date
    July 9, 2021
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSB
    UDI-DI
    00887868092732
    PMA / PMN Number
    K063570
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL DEVICES: 14-444442 FEM NAIL RETRO 13.5MM X 420MM UNKNOWN; 14-405050 TI-DBLE LEAD CORT 5.0X50MM SCR UNKNOWN; 14-405065 TI-DBLE LEAD CORT 5.0X65MM SCR UNKNOWN. FOREIGN- (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE DEVICE WAS REQUESTED BUT NOT RETURNED BY THE HOSPITAL. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVICE HISTORY RECORD (DHR) REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. ROOT CAUSE WAS UNABLE TO BE DETERMINED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2021 - 01158 - 1; 0001825034 - 2021 - 02041; 0001825034 - 2021 - 02042.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION PROCEDURE APPROXIMATELY EIGHTEEN MONTHS POST INITIAL SURGERY DUE TO KNEE PAIN. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED. IT WAS INDICATED THAT THE PAIN WAS NOT RELATED TO THE IMPLANT, IT WAS ALLEGED ON INSTRUMENTATION AND UNCERTAIN IF IT IS RELATED TO THE PROCEDURE. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1038712 TI-DBLE LEAD CORT 5.0X80MM SCR IA5.0X80MM ROD, FIXATION HSB ZIMMER BIOMET, INC. 14-405080 UNKNOWN 00887868092732

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R