BEUDAMED
    FDA Adverse Event Injury Summary report: N

    BIOMET TIBIAL TRAYS - COCR I-BEAM

    MDR report key: 6408071 · Received March 15, 2017

    Report

    Report Number
    0001825034-2017-01607
    Event Type
    Injury
    Date Received
    March 15, 2017
    Report Date
    October 17, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK142933
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). CONCOMITANT MEDICAL PRODUCTS: ITEM NAME: VANGUARD CR ILOK FEM-LT 70, ITEM NUMBER: 183032, LOT: 672500. ITEM NAME: VNGD CR LIP TIB BRG 10X71/75, ITEM NUMBER: 183540, LOT: 911790. MULTIPLE MDR REPORTS WERE FILED FOR THIS EVENT, PLEASE SEE ASSOCIATED REPORTS: 0001825034-2017-01605/01606/01607/01608/01661/01662/01663.

    Additional Manufacturer Narrative · 1

    REPORTED EVENT WAS UNABLE TO BE CONFIRMED DUE TO LIMITED INFORMATION RECEIVED FROM THE CUSTOMER. DHR WAS REVIEWED AND NO DISCREPANCIES WERE FOUND. 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

    A PATIENT WHO UNDERWENT A TOTAL KNEE ARTHROPLASTY APPROXIMATELY 9 YEARS AGO HAS BEEN INDICATED FOR A REVISION DUE TO UNKNOWN REASONS. NO REVISION HAS BEEN REPORTED TO DATE. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. NO ADDITIONAL PATIENT CONSEQUENCES WERE REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    190091 BIOMET TIBIAL TRAYS - COCR I-BEAM PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS 749570

    Patients

    Seq Age Sex Outcome Treatment
    1 Other