BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD(TM) FEMORAL DISTAL AUGMENT 10MM X 60MM LL/RM

    MDR report key: 6276243 · Received January 25, 2017

    Report

    Report Number
    0001825034-2017-00253
    Event Type
    Injury
    Date Received
    January 25, 2017
    Date of Event
    June 1, 2011
    Report Date
    May 9, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK023546
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    MEDICAL PRODUCTS - 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 OFFSET TIBIAL TRAY 63MM CATALOG# 141481 LOT# 894190, 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 1 OF 11 MDRS FILED FOR THE SAME PATIENT (REFERENCE: 0001825034 - 2017 - 00255, 0001825034 - 2017 - 00257, 0001825034 - 2017 - 00258, 0001825034 - 2017 - 00259, 0001825034 - 2017 - 00261, 0001825034 - 2017 - 00262, 0001825034 - 2017 - 00264, 0001825034 - 2017 - 00265, 0001825034 - 2017 - 00266, 0001825034 - 2017 - 00267).

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND A DISCREPANCY WAS FOUND, IT IS UNKNOWN IF IT IS RELEVANT TO THE UNKNOWN REPORTED EVENT. ROOT CAUSE WAS UNABLE TO BE DETERMINED AS THE NECESSARY INFORMATION TO ADEQUATELY INVESTIGATE THE REPORTED EVENT WAS NOT PROVIDED. IF ANY FURTHER INFORMATION IS FOUND WHICH WOULD CHANGE OR ALTER ANY CONCLUSIONS OR INFORMATION, A SUPPLEMENTAL WILL BE FILED ACCORDINGLY. ZIMMER BIOMET WILL CONTINUE TO MONITOR FOR TRENDS.

    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
    60240 VANGUARD(TM) FEMORAL DISTAL AUGMENT 10MM X 60MM LL/RM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 769060

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R