BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 54MM

    MDR report key: 2902332 · Received January 8, 2013

    Report

    Report Number
    1818910-2013-00600
    Event Type
    Injury
    Date Received
    January 8, 2013
    Date of Event
    April 19, 2010
    Report Date
    July 2, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    LPH
    PMA / PMN Number
    K070784
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    UPDATE: 12/7/2012 - MEDICAL RECORDS AND PATIENT FACT SHEET RECEIVED. OPERATIVE NOTES STATED, ACETABULAR LOOSENING SECONDARY TO FALL. THERE WAS NO BONY INGROWTH AT ALL. THE LINER, HEAD, CUP AND SCREW HAVE BEEN REPORTED. (RIGHT SIDE). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. 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 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

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, AND EXHIBITED SYMPTOMS OF A LOOSE IMPLANT. **UPDATE** 12/7/2012- MEDICAL RECORDS AND PATIENT FACT SHEET RECEIVED. OPERATIVE NOTES STATED, ACETABULAR LOOSENING SECONDARY TO FALL. THERE WAS NO BONY INGROWTH AT ALL. THE LINER, HEAD, CUP AND SCREW HAVE BEEN REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    9244 PINN SECTOR W/GRIPTION 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS, INC. 1818910 B2YET1000

    Patients

    Seq Age Sex Outcome Treatment
    1 84 YR Required Intervention