BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 58MM

    MDR report key: 4230840 · Received November 6, 2014

    Report

    Report Number
    1818910-2014-31281
    Event Type
    Injury
    Date Received
    November 6, 2014
    Date of Event
    October 10, 2014
    Report Date
    January 10, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. 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). 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.

    Additional Manufacturer Narrative · 1

    UPDATE 22 APRIL 2015. THE COMPLAINT WAS REOPENED DUE TO US RECEIVING THE PATIENTS MEDICAL RECORDS INCLUDING X-RAYS. THE X-RAYS WERE REVIEWED. NO IMPLANT FRACTURE OR IMPLANT DISASSOCIATION WAS FOUND. NO FURTHER INVESTIGATION REQUIRED PER WI-7915. THE REMAINDER OF THE INVESTIGATION REMAINS UNCHANGED. 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. 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

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, LAB RESULTS FROM (B)(6)-2010 AND (B)(6)-2011 INDICATED METAL IONS LEVELS WERE ABOVE 7PPB. THE REVISION OPERATIVE NOTE WASN'T INCLUDED, BUT THE STICKER SHEET WAS INDICATING THE FEMORAL HEAD AND LINER WERE REVISED.

    Description of Event or Problem · 1

    REPORT OF FORMAL CLAIM RECEIVED FROM KENNEDYS REGARDING REVISION OF PINNACLE MOM HIP IMPLANTS. REVISION DUE TO PAIN, POOR MOBILITY AND SLEEP DISTURBANCE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    713987 PINNACLE SECTOR II CUP 58MM HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. BJ9CF1000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention