BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC MOD DOME PATELLA 35MM

    MDR report key: 2940480 · Received February 4, 2013

    Report

    Report Number
    1818910-2013-11764
    Event Type
    Injury
    Date Received
    February 4, 2013
    Date of Event
    January 23, 2013
    Report Date
    January 23, 2013
    Manufacturer
    DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    PK884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, 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 (B)(4) APPENDIX A. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION SINCE ITS RELEASE FOR DISTRIBUTION. REVIEW OF SUPPLIED MEDICAL RECORDS CONFIRMED THE REPORTED OSTEOLYSIS, FEMORAL COMPONENT LOOSENING AND TIBIAL COMPONENT LOOSENING. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE DEVICE LOOSENING OR OSTEOLYSIS WITH THE PROVIDED INFORMATION. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE REPORTED POLYETHYLENE WEAR WITHOUT THE DEVICE TO EXAMINE; THE PATIENT SUFFERED FROM OBESITY COUPLED WITH THE LENGTH OF TIME BETWEEN DATE OF INSERTION AND DATE OF REVISION IT WOULD NOT BE UNEXPECTED TO OBSERVE SOME POLY WEAR. NO EVIDENCE AS FOUND SUGGESTING PRODUCT ERROR WAS CONTRIBUTING FACTOR. BASED ON THE INABILITY TO IDENTIFY PRODUCT ERROR AS A CONTRIBUTING FACTOR OR DETERMINE A ROOT CAUSE, 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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS OSTEOLYSIS AND POLY WEAR. THE TIBIAL TRAY AND FEMORAL COMPONENT WERE ALSO FOUND TO BE LOOSE AT THE CEMENT/IMPLANT INTERFACE. THE MANUFACTURER OF THE CEMENT USED AT THE TIME OF ORIGINAL IMPLANTATION IS UNKNOWN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46196 PFC MOD DOME PATELLA 35MM PATELLA PROSTHESIS JWH DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDICS 012927

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention