BEUDAMED
    FDA Adverse Event Death Summary report: N

    VANGUARD CR FEMORAL LEFT INTERLOK

    MDR report key: 7275275 · Received February 15, 2018

    Report

    Report Number
    0001825034-2018-00883
    Event Type
    Death
    Date Received
    February 15, 2018
    Date of Event
    March 12, 2015
    Report Date
    August 30, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL PRODUCTS: MAXIM INTERLOK FIXED I-BEAM TIBIAL PLATE WITH LOCKING BAR CAT#: 141226, LOT#: 174380. BIOMET SERIES A STANDARD PATELLA CAT#: 184710, LOT#: 936630. VANGUARD DCM CR-LIPPED TIBIAL BEARING CAT#: 183564, LOT#: 217590. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS THE PRODUCT REMAINS IMPLANTED. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS:0001825034 - 2018 - 00883, 0001825034 - 2018 - 00884, 0001825034 - 2018 - 00885, 0001825034 - 2018 - 00886. DEVICE REMAINS IMPLANTED.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THE REPORTED DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED EIGHT YEARS AFTER KNEE ARTHROPLASTY. THERE IS NO INDICATION THAT THE OF CAUSE OF DEATH IS IMPLANT OR PROCEDURE RELATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    116947 VANGUARD CR FEMORAL LEFT INTERLOK PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 493750

    Patients

    Seq Age Sex Outcome Treatment
    1 81 YR Death