BEUDAMED
    FDA Adverse Event Injury Summary report: N

    APEX HOLE ELIM POSITIVE STOP

    MDR report key: 2161891 · Received July 11, 2011

    Report

    Report Number
    1818910-2011-12408
    Event Type
    Injury
    Date Received
    July 11, 2011
    Date of Event
    June 11, 2011
    Report Date
    June 11, 2011
    Manufacturer
    JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD.
    Product Code
    MRA
    PMA / PMN Number
    P040023
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OR, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE STERILIZATION CERTIFICATIONS FOR THE PROVIDED PRODUCT/LOT COMBINATIONS DID NOT REVEAL ANY RELATED DEVIATIONS OR ANOMALIES. PER THE STERILIZATION CERTIFICATES, VALIDATED PARAMETERS WERE MET. THE INVESTIGATION COULD NOT IDENTIFY PRODUCT CONTRIBUTION TO THE REPORTED INFECTION. 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 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

    PT WAS REVISED TO ADDRESS INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 APEX HOLE ELIM POSITIVE STOP 87MRA MRA JOHNSON & JOHNSON MEDICAL (DEPUY - SUZHOU) LTD. NA D11031396

    Patients

    Seq Age Sex Outcome Treatment
    1 58 YR Required Intervention