BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR

    MDR report key: 6988564 · Received October 30, 2017

    Report

    Report Number
    0001825034-2017-09721
    Event Type
    Injury
    Date Received
    October 30, 2017
    Date of Event
    October 2, 2017
    Report Date
    October 31, 2017
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK915132
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). MEDICAL DEVICES - VANGUARD CR FEMORAL INTERLOK # 183030 LOT # 042170. VANGUARD CR LIPPID TIBIAL BEARING # 183540 LOT # 365160. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-09719 AND 0001825034-2017-09722. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED TO ZIMMER BIOMET FOR INVESTIGATION AS THEY REMAIN IMPLANTED . THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED.

    Additional Manufacturer Narrative · 1

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED THAT THIS DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AND SHOULD NOT HAVE BEEN REPORTED. THE INITIAL REPORT SHOULD BE VOIDED AS IT WAS SUBMITTED IN ERROR.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT UNDERWENT A PATELLAR RESURFACING 10 YEARS POST INITIAL SURGERY DUE TO UNKNOWN ISSUES. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    767488 BIOMET INTERLOK FIXED CRUCIATE TIBIAL PLATE WITH LOCKING BAR PROSTHESIS KNEE JWH ZIMMER BIOMET, INC. N/A 565810

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Hospitalization| R