BEUDAMED
    FDA Adverse Event Injury Summary report: N

    E1 VNGD AS TIB BRG 11X67

    MDR report key: 6379864 · Received March 6, 2017

    Report

    Report Number
    0001822565-2017-01437
    Event Type
    Injury
    Date Received
    March 6, 2017
    Date of Event
    December 19, 2016
    Report Date
    April 19, 2017
    Manufacturer
    ZIMMER, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK113550
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION IT HAS BEEN DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE REPORTED EVENT.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED AN MDR SHOULD NOT HAVE BEEN FILED UNDER THE CURRENT MFR NUMBER. THIS EVENT WILL BE REPORTED ON 0001825034-2017-01981.

    Additional Manufacturer Narrative · 1

    THE FOLLOWING SECTIONS COULD NOT BE COMPLETED WITH THE LIMITED INFORMATION PROVIDED. (B)(4). CONCOMITANT MEDICAL PRODUCTS: VNGD PAT-SPEC CR FMRL 62.5 RT PART NUMBER: 181906 LOT NUMBER: 984390, BIOMET COCR FINNED TIB TRAY 67 MM PART NUMBER: 141232 LOT NUMBER: J3841836, SERIES A PAT THN 28 3 PEG PART NUMBER: 184782 LOT NUMBER: 478710. THIS REPORT IS 3 OF 4 FOR THIS PATIENT: 0001822565-2017-01432, 0001822565-2017-01436, 0001822565-2017-01437, 0001822565-2017-01438.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT PARTIAL RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, ON (B)(6) 2016 IT WAS REPORTED THAT THE PATIENT SUFFERED MEDIAL RETINACULAR TEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    164720 E1 VNGD AS TIB BRG 11X67 PROSTHESIS, KNEE JWH ZIMMER, INC. N/A 008610

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| R