BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 60MM

    MDR report key: 4256244 · Received November 17, 2014

    Report

    Report Number
    1818910-2014-31809
    Event Type
    Injury
    Date Received
    November 17, 2014
    Date of Event
    September 24, 2012
    Report Date
    April 26, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK070784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. PPD ALLEGES INFECTION, BUT AFTER READING THE REVISION OPERATIVE NOTE IT INDICATED PAIN, DISCOMFORT, LOOSE/MALPOSITIONED CUP, AND CYST AROUND THE GREATER TROCHANTER. EXAMINATION OF THE REPORTED DEVICES WAS NOT POSSIBLE AS THEY WERE NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES FINDS NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATIONS SINCE THEIR RELEASE TO DISTRIBUTION. THE INVESTIGATION CAN DRAW NO CONCLUSION WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    PPD AND MEDICAL RECORDS RECEIVED. THIS COMPLAINT IS LEGAL. PPD ALLEGES INFECTION, BUT AFTER READING THE REVISION OPERATIVE NOTE IT INDICATED PAIN, DISCOMFORT, LOOSE/MALPOSITIONED CUP, AND CYST AROUND THE GREATER TROCHANTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    741741 PINN SECTOR W/GRIPTION 60MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. EN7E31000

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Required Intervention