BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINNACLE SECTOR II CUP 54MM

    MDR report key: 10958969 · Received December 7, 2020

    Report

    Report Number
    1818910-2020-26330
    Event Type
    Malfunction
    Date Received
    December 7, 2020
    Date of Event
    November 17, 2020
    Report Date
    November 17, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    UDI-DI
    10603295009832
    PMA / PMN Number
    K073504
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : (B)(4). INVESTIGATION SUMMARY :NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. 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. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED, AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. DEVICE HISTORY LOT : LOT J6107R A SEARCH OF THE DEPUY NONCONFORMANCE (NC) QUALITY SYSTEM FOUND NO NC¿S ASSOCIATED WITH THIS PRODUCT/LOT COMBINATION.

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    IT WAS REPORTED THAT THE SURGEON REAMED THE ACETABULUM TO A 54 AND ATTEMPTED TO IMPLANT A 54 SHELL. THERE WAS NO BITE ON THE SHELL AT ALL SO HE PROCEEDED TO REAM UP TO A 56 AND IMPLANTED IT. THIS ADDED AROUND 7-10 MINUTES TO THE CASE. HE BELIEVED THE REAMER TO COMPONENT RELATIONSHIP WAS NOT RIGHT. I REMOVED THE WASTED IMPLANT AND REAMER AND HAD THEM WASHED. SURGERY PROLONGED: 7-10 MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1426720 PINNACLE SECTOR II CUP 54MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS KWA DEPUY ORTHOPAEDICS INC US 1217-22-054 J6107R 10603295009832

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR