BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIG C/R POROCOAT FEM LT SZ 3

    MDR report key: 2596771 · Received April 8, 2009

    Report

    Report Number
    1818910-2009-01552
    Event Type
    Injury
    Date Received
    April 8, 2009
    Date of Event
    March 10, 2009
    Report Date
    March 10, 2009
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    MBH
    PMA / PMN Number
    K062654
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EVAL WAS NOT POSSIBLE, AS THE PRODUCT WAS IMPLANTED. REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY MFG DEVIATIONS OR ANOMALIES. A SEARCH OF THE COMPLAINT DATABASE DID NOT SHOW ANY OTHER REPORTS AGAINST THE MFG LOT. THE INVESTIGATION COULD NOT VERIFY OR DRAW ANY CONCLUSIONS ABOUT 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 THE PRODUCT AND/OR ADD'L INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED. ADD'L INFO FROM USER FACILITY: DATE OF REPORT: (B)(4) 2009. BRAND NAME.: DEPUY. COMMON DEVICE NAME: KNEE IMPLANT. MANUFACTURER ADDRESS.: DEPUY ORTHOPAEDICS, INC. (B)(4). MODEL: REF 94-0013. EXPIRE DATE: 11/2013. (B)(6). (B)(4).

    Description of Event or Problem · 1

    DURING SURGERY, THE SURGEON NOTICED A DEFECT IN THE COMPONENT (A 3 MM LONG SCRATCH) AFTER IMPACTION. SURGEON FELT AS THOUGH THE SCRATCH WAS A MFG DEFECT AS OPPOSED TO AN INTRAOPERATIVE EVENT. SURGERY WAS DELAYED APPROX 30 MINUTES. ADD'L INFO FROM USER FACILITY: AFTER IMPACTION OF FEMORAL COMPONENT, A 3 MM SCRATCH IN THE COMPONENT WAS NOTICED. DEPUY ENGINEER NOTIFIED BY SALES REP, WHO CONFIRMED THAT THE SCRATCH COULD CONTRIBUTE TO AN INCREASED WEAR RATE DEPENDENT UPON LOCATION. THE SCRATCH WAS ABOUT HALFWAY BETWEEN DIRECT DISTAL AND DIRECT ANTERIOR ON THE LATERAL SIDE OF THE MEDIAL CONDYLE NEAR THE TROCHANTER GROOVE, NOT ON THE APEX OF THE DISTAL FEMORAL COMPONENT. THE KNEE WAS WORKED THROUGH A RANGE OF MOTION AND THE SCRATCH DID NOT MAKE CONTACT WITH THE TIBIAL INSERT. SURGEON FELT IT WOULD BE BEST TO LEAVE THE COMPONENT IN PLACE AS OPPOSED TO REVISING IT; FELT THE SCRATCH WAS A MFG DEFECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIG C/R POROCOAT FEM LT SZ 3 87MBH MBH DEPUY ORTHOPAEDICS, INC. NA A6AAF1000

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR