BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 52MM

    MDR report key: 2934069 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-02142
    Event Type
    Injury
    Date Received
    January 30, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 9, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT IS BEING REJECTED. IT WAS ADDED TO THIS COMPLAINT IN ERROR.

    Additional Manufacturer Narrative · 1

    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). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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

    (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT PATIENT EXPERIENCED HIP PAIN, CAUSING DIFFICULTY AMBULATING AND SLEEPING. ADDITIONALLY, IT IS ALLEGED THAT IMPLANT IS RELEASING METAL IONS INTO PATIENTS BODY.

    Description of Event or Problem · 1

    PFS AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WERE PREVIOUSLY ALLEGED, PFS ALSO ALLEGES METALLOSIS, MUSCLE DAMAGE, TENDON DAMAGE, AMBULATION AND ADL DIFFICULTIES. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, OPERATIVE FINDINGS REPORTED OF METALLOSIS, MARKED DEFICIENCY GLUTEUS MEDIUS AND LARGE COLLECTION OF FLUID. CLINICAL NOTES REPORTED OF PAIN, ELEVATED METAL IONS, CHRONIC INFLAMMATION,BURSITIS AND NECROSIS. LABORATORY RESULT FOR METAL IONS WERE BELOW 7PPB. ADDED NEW COMPLAINANT INFORMATION.

    Description of Event or Problem · 1

    PPF ALLEGES METAL WEAR.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41137 PINNACLE SECTOR II CUP 52MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US B81FL1000

    Patients

    Seq Age Sex Outcome Treatment
    1 61 YR Required Intervention