BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET OFFSET TIBIAL TRAY 63MM

    MDR report key: 6276222 · Received January 25, 2017

    Report

    Report Number
    0001825034-2017-00264
    Event Type
    Injury
    Date Received
    January 25, 2017
    Date of Event
    June 1, 2011
    Report Date
    May 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    MBV
    PMA / PMN Number
    PK010212
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCT(S) - VANGUARD(TM) FEMORAL DISTAL AUGMENT 10MM X 60MM LL/RM, CATALOG# 184202, LOT# 769060. VANGUARD (TM) FEMORAL DISTAL AUGMENT 10MM X 60MM RL/LM, CATALOG# 184182, LOT# 807910. BIOMET SPLINED KNEE STEM 14MM X 120 MM, CATALOG# 141654, LOT# 485730. VANGUARD (TM) FEMORAL POSTERIOR AUGMENT 5MM X 60MM LL/RM, CATALOG# 184162, LOT# 741160. BIOMET SPLINED KNEE STEM 10MM X 80MM, CATALOG# 141610, LOT# 298100. BIOMET OFFSET TIBIAL TRAY ADAPTOR 5.0 MM, CATALOG# 141491, LOT# 326010. VANGUARD (TM) FEMORAL POSTERIOR AUGMENT 5MM X 60 MM RL/LM, CATALOG# 184142, LOT# 668770. BIOMET SERIES A THIN PATELLA 37MM X 8.6 MM, CATALOG# 184788, LOT# 968230,.VANGUARD (TM) DCM TIBIAL BEARING 20MM X 63/67 MM SMALL POST, CATALOG# 183830, LOT# 073550. CUSTOM TITANIUM VANGUARD SSK FEMORAL, CATALOG# CP113123, LOT# 474920. EVENT IS BEING REPORTED TO FDA ON ELEVEN MEDWATCHES SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE OCCURRED. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING THE REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. THIS REPORT IS NUMBER 8 OF 11 MDRS FILED FOR THE SAME PATIENT (REFERENCE 0001825034 - 2017 - 00253 , 0001825034 - 2017 - 00255 , 0001825034 - 2017 - 00257 , 0001825034 - 2017 - 00258, 0001825034 - 2017 - 00259 , 0001825034 - 2017 - 00261, 0001825034 - 2017 - 00262 , 0001825034 - 2017 - 00265 , 0001825034 - 2017 - 00266 ,0001825034 - 2017 - 00267 ).

    Additional Manufacturer Narrative · 1

    UPON RECEIPT OF ADDITIONAL INFORMATION, IT WAS DETERMINED THAT THIS DEVICE SHOULD NOT HAVE BEEN REPORTED AS IT WAS NOT INVOLVED IN THE EVENT. THE INITIAL REPORT WAS SUBMITTED IN ERROR AND SHOULD BE VOIDED.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO UNKNOWN REASONS SEVEN (7) MONTHS POST IMPLANTATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    59294 BIOMET OFFSET TIBIAL TRAY 63MM PROSTHESIS, KNEE MBV BIOMET ORTHOPEDICS N/A 894190

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R