BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC OFFSET TIB TRAY LM/RL S3

    MDR report key: 4092355 · Received September 16, 2014

    Report

    Report Number
    1818910-2014-28173
    Event Type
    Injury
    Date Received
    September 16, 2014
    Date of Event
    September 9, 2014
    Report Date
    September 9, 2014
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    JWH
    PMA / PMN Number
    PK884796
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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. 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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATION, HOWEVER DHR REVIEWS WERE CONDUCTED PER (B)(4) REQUEST, NO NONCONFORMANCES WERE NOTED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. PATIENT X-RAYS WERE RECEIVED AND REVIEWED BY COMMERCIALIZED PRODUCT DEVELOPMENT ((B)(4)). THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 THE ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    2ND REVISION: TOTAL KNEE (LEFT) PERFORMED ON (B)(6) 2014 AT THE (B)(6). REASON: PATIENT COMPLAINING OF TIBIAL PAIN, POSSIBLE TIBIAL LOOSENING. ALL COMPONENTS REVISED. FORM INDICATES PRODUCTS DISCARDED. PHOTOGRAPHS AVAILABLE. PT DETAILS: (B)(6), FEMALE, (B)(6) YRS. ALL EXPLANT DETAILS TO BE FORWARDED. PHOTOS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    572732 PFC OFFSET TIB TRAY LM/RL S3 KNEE TIBIAL TRAY JWH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC 1950133A

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention