BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT28IDX50OD

    MDR report key: 2413462 · Received January 12, 2012

    Report

    Report Number
    1818910-2012-00536
    Event Type
    Injury
    Date Received
    January 12, 2012
    Date of Event
    December 1, 2005
    Report Date
    November 15, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K002883
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT 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.

    Additional Manufacturer Narrative · 1

    **UPDATE: (B)(4) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE XVP79 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORDS FOR THE 1973254 LOT CODE DID NOT REVEAL ANY RELATED MANUFACTURING DEVIATIONS OR ANOMALIES. A COMPLAINT DATABASE SEARCH FINDS NO OTHER REPORTED INCIDENTS AGAINST THE REMAINING PRODUCT AND LOT COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. PER INTERNAL PROCEDURES, THE EVENT INFORMATION AND ANY INVESTIGATIONAL INPUTS RECEIVED AS PART OF REQUIRED FOLLOW UP WERE REVIEWED. FOR THIS INVESTIGATION, NO IMMEDIATE ACTION WAS REQUIRED AS NO ALLEGED DEFICIENCY WITH THE DEVICE WAS IDENTIFIED. MONITOR ¿ HIP IMPLANT ¿ MOM BEARING COUPLE. NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE ALLEGED ADVERSE SYMPTOMS, AND THE PRODUCT CODE REPORTED, ARE ASSOCIATED WITH THE ARTICULATION BETWEEN DEPUY METAL-ON-METAL PRODUCTS. PER WI-3430, IT HAS BEEN DETERMINED THAT SHOULD ADDITIONAL REPORTS BE IDENTIFIED FOR RELATED METAL-ON-METAL COMPLICATIONS, A DEVICE HISTORY RECORD (DHR) REVIEW IS NOT REQUIRED. THEREFORE, A COMPLAINT DATABASE SEARCH AND/OR DEVICE MANUFACTURING REVIEW WILL NOT BE PERFORMED FOR THE REPORTED PRODUCT ASSOCIATED WITH THIS INVESTIGATION. INVESTIGATIONAL INPUTS WERE REQUESTED AS INDICATED PER INTERNAL PROCEDURES FOR THIS FAILURE MODE. THE COMPLAINT INFORMATION PROVIDED HAS BEEN REVIEWED FOR COMPLAINT CODING, MEDICAL DEVICE REPORTING, AND OTHER DATA REQUIRED BY THE COMPLAINT SYSTEM. FOLLOW-UP FOR ADDITIONAL EVENT INFORMATION, IF APPLICABLE, WAS CONDUCTED UTILIZING WORK INSTRUCTION WI-7915 APPENDIX A. WITHOUT THE PHYSICAL COMPLAINT SAMPLE ASSOCIATED WITH THIS REPORT, IT WAS NOT POSSIBLE TO DETERMINE IF THE DEVICE FAILED TO MEET SPECIFICATIONS AT THE TIME IT WAS RELEASED FOR DISTRIBUTION. THE DEVICE ASSOCIATED WITH THIS EVENT WAS USED IN THE TREATMENT OF THE PATIENT AS PRESCRIBED BY THE PRESIDING SURGEON. FROM THE EVENT INFORMATION RECEIVED, IT WAS NOT POSSIBLE TO DETERMINE THE RELATIONSHIP OF THE DEVICE TO THE REPORTED EVENT. NO EVIDENCE WAS FOUND INDICATING PRODUCT ERROR WAS A CONTRIBUTING FACTOR. THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFO BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    LITIGATION ALLEGES: IN 2002, PATIENT WAS IMPLANTED WITH A DEPUY PINNACLE MOM IMPLANT IN HER RIGHT HIP. PATIENT SUFFERED DEBILITATING PAIN, SWELLING, INFLAMMATION, INFECTION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. IN (B)(6) 2005, PATIENT WAS REVISED AND IMPLANTED WITH A NEW PINNACLE MOM DEVICE. IN 2010, THE NEW IMPLANT BEGAN SLIPPING OUT OF THE SOCKET CAUSING INTENSE PAIN, DISCOMFORT, AND THE INABILITY TO WALK WITHOUT ASSISTANCE. PATIENT IS UNABLE TO BE REVISED A SECOND TIME DUE TO TOO LITTLE BONE STRUCTURE REMAINING.

    Description of Event or Problem · 1

    PPF ALLEGES CONSTRAINED LINER, BONE FRACTURE, COMPONENT FRACTURE, DISLOCATION WITH OPEN AND CLOSED REDUCTION, INFECTION, LOOSENING OF THE STEM, METAL WEAR, METALLOSIS, AND ELEVATED METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT28IDX50OD METAL LINER KWA DEPUY ORTHOPAEDICS INC US YDD37

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR Required Intervention