BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN AGC BEARING

    MDR report key: 6577907 · Received May 19, 2017

    Report

    Report Number
    3002806535-2017-00381
    Event Type
    Injury
    Date Received
    May 19, 2017
    Date of Event
    April 7, 2010
    Report Date
    May 19, 2017
    Manufacturer
    BIOMET UK LTD.
    Product Code
    JWH
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UK
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ZIMMER BIOMET COMPLAINT NUMBER - CMP-(B(4). MEDICAL PRODUCTS - UNKNOWN AGC FEMORAL AND UNKNOWN AGC TIBIAL TRAY. FOREIGN REPORT SOURCE:(B)(6). REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DEVISE HISTORY RECORDS REVIEW WAS UNABLE TO BE PERFORMED AS THE LOT NUMBER OF THE DEVICE INVOLVED IN THE EVENT IS UNKNOWN. COMPLAINT HISTORY COULD NOT BE CONDUCTED AS THE PRODUCT IDENTIFICATION IS UNKNOWN. 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. MULTIPLE MDRS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 3002806535-2017-00379 AND 3002806535-2017-003780. PRODUCT LOCATION UNKNOWN.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT A RIGHT KNEE ARTHROPLASTY. SUBSEQUENTLY, THE PATIENT UNDERWENT A REVISION PROCEDURE DUE TO DISSOCIATION AND PERI-PROSTHETIC FRACTURE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    360121 UNKNOWN AGC BEARING PROSTHESIS, KNEE JWH BIOMET UK LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 86 YR Hospitalization| R SEE NARRATIVE IN H10