BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MULTIHOLE W/GRIPTION 60MM

    MDR report key: 3091899 · Received May 3, 2013

    Report

    Report Number
    1818910-2013-16500
    Event Type
    Injury
    Date Received
    May 3, 2013
    Date of Event
    April 14, 2009
    Report Date
    February 16, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K071784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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

    (B)(4).

    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 2713217, 2739960A, CN7DB1000, 2609296, 2582825,C4YKD4000, BX2AW4000, AND C4YKD4000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES B49BT4000 AND Y1WA74000 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT - LITIGATION ALLEGES THAT PATIENT HAS SUFFERED SYMPTOMS INCLUDING BUT NOT LIMITED TO PAIN, SWELLING, INFLAMMATION, INFECTION, DAMAGE TO SURROUNDING BONE AND TISSUE, AND LACK OF MOBILITY. UPDATE 4/4/2013- PFS AND MEDICAL RECORDS RECEIVED. PART/LOT, DOI, DOB, AND SIDE WERE PROVIDED. LITIGATION AND OPERATIVE NOTES INDICATED THAT THE PATIENT WAS REVISED DUE TO INFECTION. ALL PRODUCTS HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    194085 PINN MULTIHOLE W/GRIPTION 60MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US CN7DB1000

    Patients

    Seq Age Sex Outcome Treatment
    1 43 YR Required Intervention