BEUDAMED
    FDA Adverse Event Injury Summary report: N

    AMK POLY PATELLA 8.5 X 34MM

    MDR report key: 3193042 · Received June 27, 2013

    Report

    Report Number
    1818910-2013-20006
    Event Type
    Injury
    Date Received
    June 27, 2013
    Date of Event
    June 18, 2013
    Report Date
    July 15, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK873197
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT MEDICAL RECORDS AND X-RAYS WERE PROVIDED FOR REVIEW. REVIEW OF THE SUPPLIED INVESTIGATIONAL INPUTS CONFIRMED DEVICE LOOSENING. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS PAIN AND PATELLA LOOSENING DUE TO A FALL AT THE BONE TO CEMENT INTERFACE. CEMENT MANUFACTURER AT THE ORIGINAL TIME OF IMPLANTATION IS UNKNOWN. POLY WEAR WAS ALSO REPORTED AND FOUND INTRAOPERATIVELY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    294205 AMK POLY PATELLA 8.5 X 34MM PATELLA JWH 1818910 DEPUY ORTHOPAEDICS, INC. XH9CH1

    Patients

    Seq Age Sex Outcome Treatment
    1 69 YR Required Intervention