BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PINN SECTOR W/GRIPTION 50MM

    MDR report key: 11425449 · Received March 5, 2021

    Report

    Report Number
    1818910-2021-04527
    Event Type
    Malfunction
    Date Received
    March 5, 2021
    Date of Event
    February 22, 2021
    Report Date
    February 22, 2021
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    UDI-DI
    10603295010296
    PMA / PMN Number
    K093646
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # : PC-(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 : THROUGH PRODUCT TRENDING IT IS RECOGNIZED THAT AN INCREASE IN THIS ALLEGATION HAS BEEN IDENTIFIED. NONCONFORMANCE REPORTS (NR) (B)(4), APEX HOLE ELIMINATOR, (NR) (B)(4) AND (NR) (B)(4) ACETABULAR CUP, HAVE BEEN ESTABLISHED TO FURTHER INVESTIGATE THIS ISSUE. MRE NOT PERFORMED.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE APEX HOLE ELIMINATOR WENT THROUGH CUP. SURGICAL DELAY: 30MINS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320651 PINN SECTOR W/GRIPTION 50MM PINNACLE HIP SYSTEM : HIP METAL ACETABULAR CUPS KWA DEPUY ORTHOPAEDICS INC US 1217-32-050 9642367 10603295010296

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Required Intervention APEX HOLE ELIM POSITIVE STOP| PINN SECTOR W/GRIPTION 50MM| UNK HIP ACETABULAR HOLE ELIMINATOR