BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN SECTOR W/GRIPTION 50MM

    MDR report key: 9854334 · Received March 19, 2020

    Report

    Report Number
    1818910-2020-08634
    Event Type
    Injury
    Date Received
    March 19, 2020
    Date of Event
    July 14, 2014
    Report Date
    February 28, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295010296
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    THIS IS A DUPLICATE REPORT OF 1818910-2019-101626. 1818910-2020-08634 IS BEING RETRACTED AS IT IS A REPORT DUPLICATION. 1818910-2019-101626 WILL BE KEPT FOR INVESTIGATION PURPOSES.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESS FAILED TOTAL HIP ARTHROPLASTY ON THE LEFT SECONDARY TO METAL ON METAL REACTIVE BONE AND SOFT TISSUE DISEASE. THERE WAS ALSO PAIN REPORTED. REVISION NOTES REPORTED THAT THERE WAS EXTENSIVE METALLOSIS REACTION OF THE SOFT TISSUE. THE PSEUDOTUMOR WAS VISIBLE WITHIN THE TROCHANTER REGION AT THE LEVEL OF THE BAND AND EXTENDED PROXIMALLY AND DISTALLY. THE ENTIRE TROCHANTERIC REGION HAD BEEN DESTROYED BY THE PSEUDOTUMOR AND LOST THE ATTACHMENT OF THE ADDUCTORS AND BONE EROSION OF THE TROCHANTER. THERE WAS ALSO SIGNIFICANT AMOUNT OF FLUID REACTION INVOLVED WHICH WAS GREY AND CLOUDY. CUP AND SCREW WERE ALSO REMOVED. DOI: (B)(6) 2007, DOR: (B)(6) 2014, (LEFT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320017 PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS LPH DEPUY ORTHOPAEDICS INC US 1217-32-050 B46JR1000 10603295010296

    Patients

    Seq Age Sex Outcome Treatment
    1 80 YR Required Intervention