BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASCENT SYSTEM-BEARING

    MDR report key: 6210334 · Received December 28, 2016

    Report

    Report Number
    0001825034-2016-05413
    Event Type
    Injury
    Date Received
    December 28, 2016
    Date of Event
    March 22, 2017
    Report Date
    June 7, 2017
    Manufacturer
    BIOMET ORTHOPEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK982869
    Removal / Correction Number
    N/A
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    MEDICAL EQUIPMENT COMPANY TECHNICIAN/REPRESENTATIVE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY ADDITIONAL INFORMATION. THE FOLLOWING WERE REPORTED: PT INFO - (B)(6), DOB - (B)(6), SEX - FEMALE, ADVERSE EVENT AND/OR PRODUCT PROBLEM - PRODUCT PROBLEM, OUTCOMES ATTRIBUTED TO ADVERSE EVENTS - REQUIRED INTERVENTION AND HOSPITALIZATION, DATE OF EVENT - (B)(6) 2017, DESCRIBE EVENT OR PROBLEM - IT WAS REPORTED THE PATIENT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTIES. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO POLYETHYLENE WEAR CAUSED FROM THE FEMORAL COMPONENT APPROXIMATELY TWELVE YEARS POST-IMPLANTATION. THE POLYETHYLENE BEARING, PATELLA BUTTON, AND FEMORAL COMPONENT WERE REMOVED AND REPLACED. ATTEMPTS HAVE BEEN MADE AND ADDITIONAL INFORMATION ON THE REPORTED EVENT IS UNAVAILABLE AT THIS TIME. BRAND NAME - MAXIM ASCENT BEARING 12 X 63 X 67, COMMON DEVICE NAME - JWH, MODEL #/LOT - ITEM 179361, - LOT 145940, - EXP DATE: SEP 30, 2009. IMPLANT DATE - (B)(6) 2005, EXPLANT DATE - (B)(6) 2017. MEDICAL PRODUCT - BIOMET CC I-BEAM TRAY 63 MM, ITEM #: 141221, LOT #: 418410. ASCENT PRIMARY FEMORAL SMALL LEFT, ITEM #: 179012, LOT #: 772090. BIOMET ARCOM AP PATELLA 3 POST 28 MM X-SMALL, ITEM #: 11-150838, LOT #: 291950. (B)(4). DATE RECEIVED BY MFR - MARCH 29, 2017. PMA - 510K - K982869. TYPE OF REPORTS. DEVICE MANUFACTURE DATE - SEP 22, 2004.

    Additional Manufacturer Narrative · 1

    THIS FOLLOW-UP REPORT IS BEING SUBMITTED TO RELAY AND ADDITIONAL INFORMATION. COMPLAINT COULD NOT BE CONFIRMED WITH THE INFORMATION PROVIDED. DEVICE WAS NOT RETURNED FOR ANALYSIS; THEREFORE, A PRODUCT EVALUATION COULD NOT BE CONDUCTED. REVIEW OF RADIOGRAPHS WAS UNREMARKABLE AS THE POLYETHYLENE LINER IS NOT RADIO-OPAQUE. THERE ARE WARNINGS IN THE PACKAGE INSERT AND RISKS ARE ADDRESSED IN RISK DOCUMENTATION. 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. ROOT CAUSE WAS UNDETERMINED. 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 IS REPORTED THAT THE PATIENT IS BEING CONSIDERED FOR A REVISION FOR AN UNKNOWN REASON AFTER A KNEE ARTHROPLASTY.

    Description of Event or Problem · 1

    IT WAS REPORTED THE PATIENT UNDERWENT BILATERAL TOTAL KNEE ARTHROPLASTIES. SUBSEQUENTLY, THE PATIENT UNDERWENT A LEFT KNEE REVISION DUE TO POLYETHYLENE WEAR CAUSED FROM THE FEMORAL COMPONENT APPROXIMATELY TWELVE YEARS POST-IMPLANTATION. THE POLYETHYLENE BEARING, PATELLA BUTTON, AND FEMORAL COMPONENT WERE REMOVED AND REPLACED. 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
    859051 ASCENT SYSTEM-BEARING PROSTHESIS, KNEE JWH BIOMET ORTHOPEDICS N/A 145940

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Hospitalization| O| R