BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PFC SIGMA CVD INS SZ2.5 12.5MM

    MDR report key: 1031819 · Received April 17, 2008

    Report

    Report Number
    1818910-2008-01464
    Event Type
    Injury
    Date Received
    April 17, 2008
    Date of Event
    April 9, 2008
    Report Date
    April 9, 2008
    Manufacturer
    DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM
    Product Code
    JWH
    PMA / PMN Number
    K961685
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    EVALUATION WAS NOT POSSIBLE, AS THE PRODUCT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE DID NOT REVEAL ANY OTHER REPORTS AGAINST THE MFG LOT. THE INITIAL REPORTING INDICATED THE PRODUCT WAS NOT SUSPECTED OF FAILING TO MEET SPECIFICATIONS OR CONTRIBUTING TO THE EVENT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT THE ROOT CAUSE OF THE REPORTED EVENT; HOWEVER, PROVIDED INFO INDICATES PT TRAUMA AND A NON-FUNCTIONAL POSTERIOR CRUCIATE LIGAMENT WERE CONTRIBUTING FACTORS. 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 THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PT FELL SOMETIME LAST YEAR, AND BEGAN EXPERIENCING PAIN AND SOME INSTABILITY. REVISION SURGERY REVEALED NO POSTERIOR CRUCIATE LIGAMENT INTACT, AND POLY WEAR OF THE INSERT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PFC SIGMA CVD INS SZ2.5 12.5MM 87JWH JWH DEPUY ORTHOPAEDICS, INC., DEPUY-RAYNHAM NA 21278A

    Patients

    Seq Age Sex Outcome Treatment
    1 68 YR Required Intervention