BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 60MM

    MDR report key: 2934754 · Received January 30, 2013

    Report

    Report Number
    1818910-2013-01407
    Event Type
    Injury
    Date Received
    January 30, 2013
    Report Date
    December 31, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    KWA
    PMA / PMN Number
    K000306
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE INVESTIGATION IS ONGOING. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL RELATED REPORTS FOR THE REPORTED PART AND LOT CODE COMBINATIONS. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. 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 ANY ADDITIONAL INFORMATION BE RECEIVED TO CHANGE THE OUTCOME OF THE PERFORMED INVESTIGATION, THE COMPLAINT WILL BE RE-OPENED.

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE: PATIENT SUFFERED PAIN AND DISCOMFORT, AND CONTINUES TO SUFFER SERIOUS BODILY INJURIES AND HAS INCURRED, AND CONTINUES TO INCUR, MEDICAL EXPENSES TO TREAT PATIENTS INJURIES AND CONDITION. UPDATE - (B)(4) 2012 - PFS AND MEDICAL RECORDS RECEIVED. PART/LOT INFORMATION WAS IDENTIFIED. THE DOI WAS ALSO PROVIDED, (B)(6) 2005. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE ON EXTERNAL HARD DRIVE IF NEEDED FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    41134 PINNACLE SECTOR II CUP 60MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS, INC. 1818910 Z1YFK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other