BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY GRIPTON CUP

    MDR report key: 3141369 · Received June 3, 2013

    Report

    Report Number
    1818910-2013-18014
    Event Type
    Injury
    Date Received
    June 3, 2013
    Date of Event
    October 14, 2011
    Report Date
    May 7, 2013
    Manufacturer
    1818910 DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PATIENT

    Narratives

    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.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. REVIEW OF PROVIDED MEDICAL RECORDS BY THE DEPUY LEGAL NURSE FINDS FROM A MEDICAL PERSPECTIVE IT IS UNLIKELY THE COMPLAINT IS PRODUCT RELATED AND APPEARS TO BE POTENTIALLY RELATED TO THE SURGICAL PROCESS AND TECHNIQUE. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    PATIENT CONTACTED DEPUY AS A RESULT OF THE ASR RECALL TO INITIATE A CLAIM. MEDICAL RECORDS WERE OBTAINED. MEDICAL RECORDS INDICATE THAT THE PATIENT WAS REVISED TO ADDRESS A FAILED LEFT HIP. UPON RE-IMPLANTATION OF THE HIP IT WAS NOTED THE PATIENT'S ACETABULUM CRACKED WHILE INSERTING A NEW CUP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244258 UNKNOWN DEPUY GRIPTON CUP CUP LPH 1818910 DEPUY ORTHOPAEDICS, INC. UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 74 YR Required Intervention