BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN DEPUY PINNACLE METAL LINER

    MDR report key: 2875058 · Received December 17, 2012

    Report

    Report Number
    1818910-2012-83392
    Event Type
    Injury
    Date Received
    December 17, 2012
    Date of Event
    December 3, 2012
    Report Date
    December 3, 2012
    Manufacturer
    DEPUY IRELAND ¿ REG. # 9616671
    Product Code
    KWA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. BASED ON THE INABILITY TO IDENTIFY A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS 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 EMDR HAS BEEN SUBMITTED TO THE FDA ON (B)(4), BUT DUE TO FDA PROCESSING PROBLEMS THEY NEVER RECEIVED ACK2 OR ACK3. THE FDA ASKED US TO RESUBMIT THEM TODAY.

    Description of Event or Problem · 1

    WHILE ON A CONFERENCE CALL, IT WAS BROUGHT TO THE ATTENTION OF (B)(6) THAT A PINNACLE MOM REVISION TOOK PLACE DUE TO TISSUE REACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 UNKNOWN DEPUY PINNACLE METAL LINER ACETABULAR LINER KWA DEPUY IRELAND ¿ REG. # 9616671 UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention