BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE 100 ACET CUP 56MM

    MDR report key: 3161362 · Received June 11, 2013

    Report

    Report Number
    1818910-2013-18563
    Event Type
    Injury
    Date Received
    June 11, 2013
    Date of Event
    September 28, 2012
    Report Date
    May 28, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    KWA
    PMA / PMN Number
    PK003523
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THIS PRODUCT, (B)(4), WAS REPORTED IN ERROR. DUE TO THE PROBLEMS BEING REPORTED/REASONS FOR REVISION, THE CUP AND SLEEVE ARE NOT THE SUBJECT OF THE COMPLAINT.

    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

    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.

    Description of Event or Problem · 1

    THE COMPLAINT HAS BEEN REOPENED BECAUSE IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2013 TO ADDRESS OSTEOLYSIS. A SMALL PART OF THE GREATER TROCHANTER HAD PULLED OFF (REASONABLE TO CONCLUDE THIS WAS DUE TO THE OSTEOLYSIS). SIGNIFICANT METAL DEBRIS WAS FOUND AT THE TRUNNION OF THE HEAD AND STEM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    262694 PINNACLE 100 ACET CUP 56MM ACETABULAR CUP KWA 1818910 DEPUY ORTHOPAEDICS, INC. W4KGD1016

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention