BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC

    MDR report key: 5881838 · Received August 17, 2016

    Report

    Report Number
    0001825034-2016-03104
    Event Type
    Injury
    Date Received
    August 17, 2016
    Report Date
    July 19, 2016
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PNI
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CURRENT INFORMATION IS INSUFFICIENT TO PERMIT CONCLUSIONS AS TO THE CAUSE OF THE EVENTS. EVENT DETAILS AND PRODUCT IDENTIFICATION WAS NOT PROVIDED FOR THE PATIENT MENTIONED IN THE JOURNAL ARTICLE. INITIAL REPORTER - THE ARTICLE WAS WRITTEN BY JOSHUA L. CARTER, HENRY D. CLARK, MICHAEL E. BEREND, JOHN B. MEDING, AND KENNETH E. DAVIS. EVENT IS BEING REPORTED TO FDA ON ONE MEDWATCH SINCE THE LIMITED INFORMATION AVAILABLE INDICATES THAT A REVISION PROCEDURE MAY BE NECESSARY. SHOULD ADDITIONAL INFORMATION BE RECEIVED REGARDING A REVISION PROCEDURE, THE COMPLAINT WILL BE REASSESSED AND, IF WARRANTED, FURTHER MEDWATCH REPORTS WILL BE SUBMITTED. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    INFORMATION WAS RECEIVED BASED ON REVIEW OF A JOURNAL ARTICLE TITLED, ¿DOES COMPONENT SIZE ¿MISMATCH¿ LEAD TO HIGHER FAILURE RATES IN TOTAL KNEE ARTHROPLASTY?¿ WHICH AIMS TO EXAMINE A LARGE PROSPECTIVE TOTAL KNEE ARTHROPLASTY DATABASE FOR THE OUTCOMES OF ¿MATCHED¿ AND MISMATCHED¿ IMPLANT COMBINATIONS, COMPARING THE AGC AND VANGUARD KNEE PROSTHESES IMPLANTED FROM 1984 TO 2015. FORTY-FIVE PROSTHESES WERE IDENTIFIED IN THE ARTICLE THAT HAD MATCHED TIBIAL AND FEMORAL COMPONENTS AND EXPERIENCED FAILURE. THERE HAS BEEN NO FURTHER INFORMATION PROVIDED AND PATIENT OUTCOMES ARE UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    534000 UNKNOWN AGC PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A NI

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R