BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA/OV/DOME PAT 3PEG, 41

    MDR report key: 2111408 · Received May 13, 2011

    Report

    Report Number
    1818910-2011-08378
    Event Type
    Injury
    Date Received
    May 13, 2011
    Date of Event
    April 13, 2011
    Report Date
    April 13, 2011
    Manufacturer
    DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE SUBMITTED DEVICES DID NOT REVEAL ANY EVIDENCE OF PRODUCT FAILURE OR PRODUCT CONTRIBUTION TO THE REPORTED PATIENT PAIN AND TIGHTNESS IN EXTENSION. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY ADDITIONAL RELATED REPORTS AGAINST THE LOT CODE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT. NO EVIDENCE WAS FOUND SUGGESTING PRODUCT ERROR WAS A CONTRIBUTING FACTOR AND THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    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

    PT WAS REVISED TO ADDRESS PAIN IN KNEE AND TIGHTNESS IN EXTENSION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA/OV/DOME PAT 3PEG, 41 87JWH JWH DEPUY-CORK, A DIVISION OF DEPUY ORTHOPAEDICS NA 3061892

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention