BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MULTIHOLE II CUP 48MM

    MDR report key: 2972437 · Received February 21, 2013

    Report

    Report Number
    1818910-2013-12700
    Event Type
    Injury
    Date Received
    February 21, 2013
    Date of Event
    February 7, 2013
    Report Date
    February 7, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    PATIENT WAS REVISED TO ADDRESS SUBLUXATION. POLY WEAR AND OSTEOLYSIS WERE ALSO REPORTED. IT WAS NOTED THAT THE LINER CAME OUT OF THE CUP EASILY, WITHOUT NEEDING THE REMOVAL TOOL. DOI UNK - DOR (B)(6) 2013 (HIP). AS REPORTED, EXAMINATION OF THE RETURNED DEVICES FINDS EVIDENCE OF SUBLUXATION WHILE IMPLANTED. THERE IS ALSO EVIDENCE INDICATING THE LINER WAS NOT PROPERLY ENGAGED WITH THE CUP AND THAT A PROUD BONE SCREW MAY HAVE BEEN A CONTRIBUTING FACTOR. A COMPLAINT DATABASE SEARCH FINDS NO ADDITIONAL REPORTS AGAINST THE KNOWN PRODUCT/LOT COMBINATIONS. THE INVESTIGATION HAS NOT IDENTIFIED PRODUCT ERROR WITH REGARD TO THIS REPORT. BASED ON THE INVESTIGATION THE NEED FOR CORRECTIVE ACTION IS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    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.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS SUBLUXATION. POLY WEAR AND OSTEOLYSIS WERE ALSO REPORTED. IT WAS NOTED THAT THE LINER CAME OUT OF THE CUP EASILY, WITHOUT NEEDING THE REMOVAL TOOL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    75941 PINNACLE MULTIHOLE II CUP 48MM ACETABULAR CUP LPH 1818910 DEPUY ORTHOPAEDICS, INC. Z1RGA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR Required Intervention