BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD PS TIB BRG 63/67X16 X 16

    MDR report key: 10374869 · Received August 6, 2020

    Report

    Report Number
    0001825034-2020-03090
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    February 2, 2020
    Report Date
    September 22, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304465633
    PMA / PMN Number
    K113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. UPDATED: B4, B5, G4, H2, H3, H6, H10. . D11: MEDICAL PRODUCTS: PN: 184520, VNGD PS OPEN POR FMRL LT, LN: 966170. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES RELEVANT TO THE REPORTED EVENT WERE FOUND. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. 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 · 0

    NO FURTHER EVENT INFORMATION AVAILABLE AT THE TIME OF THIS REPORT.

    Additional Manufacturer Narrative · 1

    (B)(4). ASSOCIATED PRODUCTS : ITEM#: 141205 BIOMET TIBIAL LOCKING BAR LOT#:588070. ITEM#: 141314 BIOMET FINNED PRI STEM 40MM LOT#:761940. ITEM#: 141355 RGX 3 PEG SER A PATELLA 28MM LOT#:006170. ITEM#: 141271 BMET REGENX PRI TIB TRAY 63MM COCR 63MM LOT#:030910. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS ITS LOCATION IS UNKNOWN. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034 - 2020 - 03094. 0001825034 - 2020 - 03093. 0001825034 - 2020 - 03092. 0001825034 - 2020 - 03091.

    Description of Event or Problem · 1

    PATIENT¿S LEGAL COUNSEL REPORTED PATIENT UNDERWENT LEFT KNEE ARTHROPLASTY FOUR YEARS AGO. LEGAL COUNSEL FURTHER REPORTS PATIENT UNDERWENT A REVISION PROCEDURE SIX MONTHS AGO FOR UNKNOWN REASONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    838660 E1 VNGD PS TIB BRG 63/67X16 X 16 PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 984900 00880304465633

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R