BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGMA PS CEM FEM SZ3 R

    MDR report key: 2881961 · Received December 20, 2012

    Report

    Report Number
    1818910-2012-84024
    Event Type
    Injury
    Date Received
    December 20, 2012
    Date of Event
    December 12, 2012
    Report Date
    December 12, 2012
    Manufacturer
    DEPUY (IRELAND)
    Product Code
    JWH
    PMA / PMN Number
    PK073529
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. IT WAS INITIALLY REPORTED THAT THE PRODUCT WOULD BE PROVIDED. TO DATE, CUSTOMER QUALITY HAS NOT RECEIVED ANY ADDITIONAL EVENT INFORMATION AND IT HAS SINCE BEEN REPORTED THE PRODUCT WOULD NOT BE RETURNED. AN ENGINEERING X-RAY REVIEW WAS PERFORMED. TWO X-RAY IMAGES WERE PROVIDED, ONE A/P AND ONE M/L. BOTH IMAGES DID NOT SHOW THE DATE OF X-RAY PROCEDURE AND THEY WERE BOTH OF POOR IMAGE QUALITY. THE A/P IMAGE SUGGESTS SUBSIDENCE OR ABNORMAL SLOPE OF THE MEDIAL TIBIAL PLATEAU, RESULTING IN A VARUS DEFORMITY OF THE KNEE. THE M/L IMAGE SUGGESTS AN EXTREME POSTERIOR TIBIAL SLOPE. HOWEVER, IT IS DIFFICULT TO DETERMINE THE IMMEDIATE POST-OP POSITION OF THE TIBIAL BASE SINCE A CHRONOLOGICAL SEQUENCE OF X-RAY IMAGES WAS NOT PROVIDED. THE REVISION SURGERY TOOK PLACE 2.5+ YEARS AFTER THE INITIAL SURGERY ACCORDING TO THE NOTES ON COM-001182. PATIENT BMI INFORMATION WAS NOT PROVIDED. THE REPORTED COMPLAINT OF PAIN AND CLUNKING CANNOT BE CONFIRMED WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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

    PATIENT REVISED FOR PAIN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGMA PS CEM FEM SZ3 R DEPUY KNEE IMPLANT JWH DEPUY (IRELAND) 3202983

    Patients

    Seq Age Sex Outcome Treatment
    1 76 YR Required Intervention