BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT36IDX56OD

    MDR report key: 2915078 · Received January 15, 2013

    Report

    Report Number
    1818910-2013-00818
    Event Type
    Injury
    Date Received
    January 15, 2013
    Report Date
    December 17, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. NOT RETURNED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE LOT CODES YX8LM1000, 2598626, 2358009, YK9EF1000, AND 1170026. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1218598 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE PART AND LOT CODE COMBINATION WAS NOT PROVIDED FOR THE BONE SCREW. MEDICAL RECORDS WERE RECEIVED AND REVIEWED. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    UDI: (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THAT THE PATIENT WAS REVISED TWICE FOR PAIN AND DISCOMFORT. UPDATE: (B)(4) 2012 - WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS INDICATE THAT (B)(6) 2004 PRIMARY IMPLANT; (B)(6) 2008 HIP WAS ASPIRATED, NO INFECTION FOUND, NOTHING REMOVED; (B)(6) 2009 REVISED FOR PAIN AND LOOSE STEM; (B)(6) 2010 HIP WAS ASPIRATED, NO INFECTION FOUND, NOTHING REMOVED; (B)(6) 2010 REVISED FOR LOOSE STEM, SLEEVE, CUP HAD NO BONY INGROWTH, BROKEN SCREW, POSSIBLE INFECTION. ALL PRODUCTS REMOVED ANTIBIOTIC SPACER PLACED. (B)(6) 2011 ANTIBIOTIC SPACER REMOVED, RE-IMPLANTED WITH COMPETITOR PRODUCT. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    21738 PINNACLE MTL INS NEUT36IDX56OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US 1170026

    Patients

    Seq Age Sex Outcome Treatment
    1 21 YR Required Intervention