BEUDAMED
    FDA Adverse Event Injury Summary report: N

    JGRLOC B2B RD TI SLD DRL KIT

    MDR report key: 8674664 · Received June 6, 2019

    Report

    Report Number
    0001825034-2019-02447
    Event Type
    Injury
    Date Received
    June 6, 2019
    Date of Event
    May 21, 2019
    Report Date
    September 17, 2019
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HSN
    PMA / PMN Number
    K120906
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AK, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    CORRECTED DATA: EXPIRATION DATE IS JUL 31, 2023 AND NOT APR 6, 2023. CONCOMITANT MEDICAL PRODUCTS: ITEM# 110007345; JGRLOC B2B RD TI SLD DRL KIT; LOT# 241040. COMPLAINT SAMPLE WAS EVALUATED AND THE REPORTED EVENT WAS CONFIRMED. INSPECTION OF THE RETURNED DEVICE IDENTIFIED FRAYING AND CUTS IN THE SUTURES NEAR THE BUTTONS. DEVICE HISTORY RECORD WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION HAS BEEN SENT TO THE COMPLAINANT. 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: 0001825034-2019-04167.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT DURING A SURGERY, THE TITANIUM BUTTON OF THE JUGGERLOC DID NOT FULLY ZIP DOWN, LEAVIKNG SEVERAL SEVERAL MILLIMETERS OF SLACK IN THE SUTURE MATERIAL. THERE WAS A DELAY OF 30 MINUTES AS A RESULT OF THIS EVENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Additional Manufacturer Narrative · 1

    (B)(4). CUSTOMER HAS INDICATED THAT THE PRODUCT IS IN PROCESS OF BEING RETURNED TO ZIMMER BIOMET FOR INVESTIGATION. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. DEVICE EVALUATED BY MANUFACTURER? REMAINS IMPLANTED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT DURING A SURGERY, THE TITANIUM BUTTON OF THE JUGGERLOC DID NOT FULLY ZIP DOWN. HOWEVER, AFTER MULTIPLE ATTEMPTS IT WAS IMPLANTED SUCCESSFULLY. THERE WAS A DELAY OF 30 MINUTES AS A RESULT OF THIS EVENT. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    469989 JGRLOC B2B RD TI SLD DRL KIT EXTREMITIES, IMPLANT HSN ZIMMER BIOMET, INC. N/A 241040

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Hospitalization| R