BEUDAMED
    FDA Adverse Event Injury Summary report: N

    VANGUARD PATELLA COMPONENTS - SERIES A PAT STD 31 3 PEG

    MDR report key: 6472832 · Received April 7, 2017

    Report

    Report Number
    0001825034-2017-02446
    Event Type
    Injury
    Date Received
    April 7, 2017
    Report Date
    May 31, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK040770
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THIS EVENT IS STILL UNDER INVESTIGATION. A FOLLOW UP MDR WILL BE SUBMITTED UPON COMPLETION OF THE INVESTIGATION.

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: CATALOG NUMBER 183010, ITEM NAME VANGUARD CR ILOK FEM-RT 67.5, LOT J3745962. CATALOG NUMBER 141234, ITEM NAME BIOMET CC CRUCIATE TRAY 75MM, LOT J3792126. CATALOG NUMBER EP-183440, ITEM NAME E1 VNGD CR TIB BRG 71/75X10, LOT 676960. CATALOG NUMBER 32-486265, ITEM NAME 1/8 QUICK REL DRL STERILE 2PK, LOT 862780. CATALOG NUMBER 516065, ITEM NAME UNIVERSAL Z/HALL STYL 19.7X100, LOT 262554. CUSTOMER HAS INDICATED THAT THE PRODUCT WILL NOT BE RETURNED AS IT REMAINS IMPLANTED TO ZIMMER BIOMET FOR INVESTIGATION. THE INVESTIGATION IS IN PROCESS. ONCE THE INVESTIGATION HAS BEEN COMPLETED, A FOLLOW-UP MDR WILL BE SUBMITTED. CMP-(B)(4).

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. REVIEW OF THE COMPLAINT HISTORY DETERMINED THAT NO FURTHER ACTION IS REQUIRED AS NO WERE TRENDS IDENTIFIED. THE COMPONENTS WERE REVIEWED FOR COMPATIBILITY WITH NO ISSUES NOTED. ROOT CAUSE WAS UNABLE TO BE DETERMINED. A SUMMARY OF THE INVESTIGATION WILL BE SENT TO THE COMPLAINANT. 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 A PATIENT WHO UNDERWENT A TOTAL KNEE ARTHROPLASTY APPROXIMATELY 8 MONTHS AGO HAS BEEN INDICATED FOR REVISION DUE PATELLA LOOSENING. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254615 VANGUARD PATELLA COMPONENTS - SERIES A PAT STD 31 3 PEG PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 648650

    Patients

    Seq Age Sex Outcome Treatment
    1 Other