BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE MTL INS NEUT 52 OD X 36 ID

    MDR report key: 1931409 · Received December 15, 2010

    Report

    Report Number
    1818910-2010-08875
    Event Type
    Injury
    Date Received
    December 15, 2010
    Report Date
    November 15, 2010
    Manufacturer
    DEPUY INTERNATIONAL, LTD.
    Product Code
    KWA
    PMA / PMN Number
    K003523
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    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

    (B)(4)., REPORTS: THE PATIENT WAS REVISED DUE TO PAIN ON (B)(6) 2010. DOI: (B)(6) 2007. ON (B)(6) 2007, THA WAS DONE WITH MOM. IN (B)(6) 2010, THE PATIENT HAD A PAIN AROUND THE HIP. ON (B)(6), THE INSERT AND HEAD WERE REPLACED BY OTHER PRODUCTS. THE METAL INSERT WAS REPLACED BY A POLY LINER. THE SURGEON SUSPECTED THAT PSEUDOTUMOR OCCURRED. NO X-RAYS WERE PROVIDED FROM THE HOSPITAL. CUP((B)(4)) WAS MANUFACTURED BY (B)(4). THE PRODUCTS ASSOCIATED WITH THIS REPORTED EVENT WERE NOT RETURNED FOR EXAMINATION. A SEARCH OF THE COMPLAINT DATABASES DID NOT SHOW ANY OTHER REPORTS AGAINST THE PROVIDED PRODUCT AND LOT COMBINATIONS. 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 PRODUCT AND / OR ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    THE PT WAS REVISED DUE TO PAIN, THE SURGEON SUSPECTED THAT PSEUDOTUMOR OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PINNACLE MTL INS NEUT 52 OD X 36 ID 87KWA KWA DEPUY INTERNATIONAL, LTD. NA 2415438

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention