BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POLISHED FINNED TIB TRAY 71MM

    MDR report key: 11191921 · Received January 19, 2021

    Report

    Report Number
    0009610576-2021-00001
    Event Type
    Injury
    Date Received
    January 19, 2021
    Date of Event
    January 12, 2021
    Report Date
    May 24, 2021
    Manufacturer
    BIOMET SPAIN, S.L.
    Product Code
    KRO
    PMA / PMN Number
    SEE H10
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    (B)(4). D9: PRODUCT RETURNED UNCOMPLETED, ONLY RETURNED THE LOCKING BAR, THE TIBIAL TRAY REMAINS IMPLANTED. D11: ASSOCIATED PRODUCTS: VANGUARD CR ILOK FEM-RT 62.5 REFERENCE (B)(4), LOT J6227614; SERIES A PAT STD 34 3 PEG REFERENCE (B)(6), LOT 41500. G5: THIS PRODUCT IS MANUFACTURED BY BIOMET SPAIN ORTHOPAEDICS, S.L. AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET WARSAW MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. INITIAL MFR REPORT NUMBER: 0009610576-2021-00001.

    Description of Event or Problem · 0

    COMPLAINT RECEIVED INDICATING THAT A PATIENT WENT TO HOSPITAL DUE TO PAIN AND AFTER CHECKING X-RAY FIXATION PIN/LOCKING BAR VANGUARD TIBIA WAS FOUND DISLOCATED. FIXATION HOOK WAS BROKEN. IMMEDIATE SURGERY FOLLOWED PERFORMED ON (B)(6) 2021. ONLY LOCKING BAR WAS REMOVED, TIBIAL TRAY AND FEMUR WERE LEFT IN SITU.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS. ASSOCIATED PRODUCTS: VANGUARD CR ILOK FEM-RT 62.5 REFERENCE 183006 LOT J6227614. SERIES A PAT STD 34 3 PEG REFERENCE 184766 LOT 41500. THIS PRODUCT IS MANUFACTURED BY BIOMET (B)(4) AND IS NOT CLEARED OR DISTRIBUTED IN THE U.S. HOWEVER, THIS REPORT IS BEING SUBMITTED AS ZIMMER BIOMET (B)(4) MANUFACTURES A SIMILAR DEVICE THAT IS CLEARED OR DISTRIBUTED IN THE UNITED STATES UNDER 510(K) NUMBER K945028. PRODUCT PARTIALLY REMAINS IMPLANTED.

    Description of Event or Problem · 1

    NEW COMPLAINT RECEIVED INDICATING THAT A PATIENT WENT TO HOSPITAL DUE TO PAIN AND AFTER CHECKING X-RAY FIXATION PIN/LOCKING BAR VANGUARD TIBIA WAS FOUND DISLOCATED. FIXATION HOOK WAS BROKEN. IMMEDIATE SURGERY FOLLOWED PERFORMED ON (B)(6) 2021. ONLY LOCKING BAR WAS REMOVED, TIBIAL TRAY AND FEMUR WERE LEFT IN SITU.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    95041 POLISHED FINNED TIB TRAY 71MM PROSTHESIS, KNEE KRO BIOMET SPAIN, S.L. N/A 2018090737

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention SEE H10