BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY CUP

    MDR report key: 6114222 · Received November 18, 2016

    Report

    Report Number
    1818910-2016-31652
    Event Type
    Injury
    Date Received
    November 18, 2016
    Date of Event
    September 23, 2016
    Report Date
    November 16, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO OTHER REPORTED INCIDENT(S) AGAINST THE PROVIDED PRODUCT/LOT COMBINATION(S) SINCE RELEASE FOR DISTRIBUTION. PRODUCT/LOT INFORMATION FOR THE ASSOCIATED ACETABULAR CUP IS NOT KNOWN. 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.

    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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. UDI: UNAVAILABLE. FOLLOW-UP WITH THE COMPLAINANT HAS BEEN CONDUCTED FOR THE CATALOG NUMBER AND LOT NUMBER AND THIS INFORMATION IS NOT AVAILABLE.

    Description of Event or Problem · 1

    THE PATIENT WAS REVISED DUE TO THE LOCKING RING DISASSOCIATING FROM THE LINER. THE PATIENT DISLOCATED WHEN THEY BENT OVER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    765618 UNKNOWN DEPUY CUP HIP ACETABULAR CUP LPH DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention