BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC*CVD TB INS,SZ3, 12.5MM

    MDR report key: 3800441 · Received May 8, 2014

    Report

    Report Number
    1818910-2014-18361
    Event Type
    Injury
    Date Received
    May 8, 2014
    Date of Event
    April 17, 2014
    Report Date
    June 5, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    JWH
    PMA / PMN Number
    PK884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: 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 WERE PROVIDED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A LOT SPECIFIC COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE FOR THE PRODUCT LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. DUE TO THE FACT THAT THE PATIENT WAS MORBIDLY OBESE COUPLED WITH THE LENGTH OF TIME BETWEEN DATE OF INSERTION AND THE DATE OF REVISION, IT WOULD NOT BE UNEXPECTED TO OBSERVE POLY WEAR. BASED ON THE INABILITY TO IDENTIFY 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.

    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. 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 INSTABILITY RESULTING FROM POLY WEAR. PAIN WAS ALSO REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    277554 PFC*CVD TB INS,SZ3, 12.5MM KNEE TIBIAL BEARING/INSERT JWH DEPUY ORTHOPAEDICS, INC. UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 89 YR Required Intervention