BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN MAR NEUT 28IDX46OD

    MDR report key: 10437254 · Received August 21, 2020

    Report

    Report Number
    1818910-2020-18539
    Event Type
    Injury
    Date Received
    August 21, 2020
    Date of Event
    August 10, 2020
    Report Date
    August 10, 2020
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295013273
    PMA / PMN Number
    K033273
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    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.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (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 PATIENT HAD RE-OCCURRENCE DISLOCATION. DS ACETABULAR CUP/LINER WAS EXPLANTED, FEMORAL HEAD REMOVED, THEN A COMPETITOR MDM CONSTRUCT IMPLANTED ALONG WITH A DS 22 MM FEMORAL HEAD. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    903946 PINN MAR NEUT 28IDX46OD PINNACLE HIP SYSTEM : HIP POLY ACETABULAR LINERS LPH DEPUY ORTHOPAEDICS INC US 1219-28-046 698045 10603295013273

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Required Intervention ARTICUL/EZE BALL 28 +5 BR| PINN MAR NEUT 28IDX46OD| PINNACLE BANTAM ACET CUP 46MM| ARTICUL/EZE BALL 28 +5 BR| PINN MAR NEUT 28IDX46OD| PINNACLE BANTAM ACET CUP 46 MM