BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT40IDX58OD

    MDR report key: 2872270 · Received December 13, 2012

    Report

    Report Number
    1818910-2012-83684
    Event Type
    Injury
    Date Received
    December 13, 2012
    Date of Event
    December 5, 2012
    Report Date
    December 5, 2012
    Manufacturer
    DEPUY INTERNATIONAL
    Product Code
    KWA
    PMA / PMN Number
    PK083642
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    EXAMINATION OF THE RETURNED DEVICES BY A DEPUY CPD ENGINEER FINDS NOTHING OUTWARD TO SUGGEST PRODUCT PROBLEM. EXAMINATION OF THE PROVIDED PATIENT X-RAYS FINDS THE IMPLANTS APPEAR TO BE PLACED IN PROPER POSITION. IT CANNOT BE DETERMINED, WITH THE X-RAYS PROVIDED, THAT THE COMPLAINT IS PRODUCT RELATED. REVIEW OF DEVICE HISTORY RECORDS AND STERILIZATION CERTIFICATIONS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT/LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. ADDITIONALLY, RESEARCH FINDS SEVERAL OTHER DEVICES FROM EACH OF THE REPORTED LOTS SHOW DELIVERED TO AN END CUSTOMER AND AS NO OTHER REPORTS HAVE BEEN RECEIVED, IT IS ASSUMED THEY HAVE BEEN IMPLANTED SUCCESSFULLY WITHOUT ISSUE. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. IT SHOULD BE NOTED, THE PATIENT WAS IMPLANTED (B)(6) 2011 AND REVISED ON (B)(6) 2012. INFECTION MORE THAN 1.5 YEARS POST-PRIMARY IS NOT LIKELY TO BE DEVICE RELATED. BASED ON THE PERFORMED INVESTIGATION AND INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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

    CONSULTATIONFOR PROGRESSIVE THIGH PAIN. IT WAS DECIDED TO REPLACE THE MOM BEARING COUPLE WITH A CERAMIC ON CERAMIC BEARING COUPLE. ALVAL WAS SUSPECTED. DURING REVISION SURGERY, ASPECT OF PERIARTICULAR TISSUE NECROSIS WAS CONFIRMED BY HISTOLOGICAL EXAMINATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT40IDX58OD DEPUY HIP IMPLANT KWA DEPUY INTERNATIONAL 3150848

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention