BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VANGUARD TIBIAL BEARING

    MDR report key: 7135596 · Received December 20, 2017

    Report

    Report Number
    0001825034-2017-11302
    Event Type
    Injury
    Date Received
    December 20, 2017
    Report Date
    April 4, 2018
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    HRY
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: VANGUARD FEM PEGS SET 2, CATALOG # 183099, LOT # 611020; VAN PS OPEN INTL FEM-RT 62.5, CATALOG # 183106, LOT # 833000; SERIES A PAT STD 31 3 PEG, CATALOG # 184764, LOT # 596500; OSC FAN BLADE S2K HUB, CATALOG # 506096, LOT # 952033. THIS FOLLOW-UP REPORT IS BEING FILLED TO RELAY ADDITIONAL INFORMATION, WHICH WAS UNKNOWN A THE TIME OF THE INITIAL MEDWATCH.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: BIOMET CC CRUCIATE TRAY CAT#: 141232, LOT#: J3563876. (B)(6). CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION, AS PRODUCT LOCATION IS UNKNOWN. 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. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-11301.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO NOT BE REPORTABLE. THERE ARE NO ALLEGATIONS OF FAILURE OF THE DEVICE AND THE INITIAL REPORT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION AFTER TOTAL KNEE ARTHROPLASTY DUE TO TIBIAL LOOSENING. SMALL HOLES WERE SEEN ON THE EXPLANTED BEARING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    913226 E1 VANGUARD TIBIAL BEARING PROSTHESIS, KNEE HRY ZIMMER BIOMET, INC. N/A 976050

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R