BEUDAMED
    FDA Adverse Event Injury Summary report: N

    DELTA CER HEAD 12/14 36MM +5

    MDR report key: 2942986 · Received February 5, 2013

    Report

    Report Number
    1818910-2013-11850
    Event Type
    Injury
    Date Received
    February 5, 2013
    Date of Event
    February 4, 2013
    Report Date
    February 4, 2013
    Manufacturer
    DEPUY IRELAND 9616671
    Product Code
    KWA
    PMA / PMN Number
    PK031803
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    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

    DUE TO NO SIMILAR FAILURES FOUND IN THE DHR REVIEW, THE ROOT CAUSE OF THE COMPLAINT CANNOT BE DETERMINED THROUGH DEPUY CORK¿S INVESTIGATION. RETURNED PRODUCT WILL HAVE A PRODUCT ANALYSIS CONDUCTED BY THE SUPPLIER. SHOULD FURTHER INFORMATION COME AVAILABLE THAT IMPACTS THE FINDINGS IN THIS INVESTIGATION IT WILL BE REOPENED.

    Additional Manufacturer Narrative · 1

    THE COMPLAINT WAS ORIGINALLY RECEIVED INTO (B)(4) 4 FEB 2013 WITH THE COMMENT: REVISION - 4TH FEB. REASON FOR REVISION: DISLOCATION X-RAYS AVAILABLE PS WILL EMAIL SEPARATELY COMPLETED SUCCESSFULLY. ORIGINAL IMPLANT DATE: (B)(6) 2010 PATIENTS INITIAL: (B)(6) DOB: (B)(6) 1947 PRODUCTS REPLACED: 121832652 - 197716 136532720 - 3005988 124603000 - D1210910 NO RESOLUTION LETTER REQUIRED. THE INITIAL INVESTIGATION CONDUCTED BY CORK ONLY REFERENCED A DHR REVIEW FOR ONE PRODUCT AND ALSO INCORRECTLY STATED THAT THE CERAMIC HEAD WOULD BE SENT TO THE SUPPLIER FOR INVESTIGATION WHEN THE CUSTOMER HAD NOT RETURNED THE PRODUCT AND HAD NEVER STATED THAT THE PRODUCT WOULD BE AVAILABLE FOR INVESTIGATION. THE CUSTOMER INFORMED US THAT THEY WOULD LIKE US TO REINVESTIGATE THE COMPLAINT AND SO THE COMPLAINT WAS RE-OPENED AND INVESTIGATED IN (B)(4). A DHR REVIEW AND COMPLAINT SEARCH IDENTIFIED NO ANOMALIES OR PREVIOUS COMPLAINTS INVOLVING THE LOT NUMBERS OF THE PRODUCTS IN THIS PROCEDURE. AS NO FURTHER INFORMATION WAS PROVIDED, NO FURTHER INVESTIGATION COULD BE CONDUCTED. THE COMPLAINT SHALL BE CLOSED AS UNDETERMINED; NO PRODUCT PROBLEM IDENTIFIED. DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    REASON FOR REVISION: DISLOCATION XRAYS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    48921 DELTA CER HEAD 12/14 36MM +5 CERAMIC FEMORAL HEAD KWA DEPUY IRELAND 9616671 3183296

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention