BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL LOCKING BAR

    MDR report key: 10374852 · Received August 6, 2020

    Report

    Report Number
    0001825034-2020-03094
    Event Type
    Injury
    Date Received
    August 6, 2020
    Date of Event
    February 2, 2020
    Report Date
    September 16, 2020
    Manufacturer
    ZIMMER BIOMET, INC.
    Product Code
    JWH
    UDI-DI
    00880304009738
    PMA / PMN Number
    K171054
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    UPON REASSESSMENT OF THE REPORTED EVENT, IT WAS DETERMINED TO BE NOT REPORTABLE. DEVICE DID NOT CAUSE OR CONTRIBUTE TO THE EVENT AS IT WAS NOT IMPLANTED. THE INITIAL REPORT WAS FORWARDED IN ERROR AND SHOULD BE VOIDED.

    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#: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. ITEM#:EP-183626; E1 VNGD PS TIB BRG 63/67X16 X 16 LOT#:984900. 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 - 03093. 0001825034 - 2020 - 03092. 0001825034 - 2020 - 03091. 0001825034 - 2020 - 03090.

    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
    838395 BIOMET TIBIAL LOCKING BAR PROSTHESIS, KNEE JWH ZIMMER BIOMET, INC. N/A 588070 00880304009738

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R