BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 56MM

    MDR report key: 2962103 · Received February 14, 2013

    Report

    Report Number
    1818910-2013-03820
    Event Type
    Injury
    Date Received
    February 14, 2013
    Date of Event
    January 30, 2012
    Report Date
    January 16, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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 LOT CODES 2954995, 2952984, SW1HK1, AND DP6BG1. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST BOTH LOT CODES 536725 AND 411200 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. 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.

    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

    PATIENT WAS REVISED TO ADDRESS PAIN AND ADVERSE METAL REACTION. THERE WAS A LARGE FLUID COLLECTION POSTERIOR, AS WELL AS OSTEOLYSIS. UPDATE: (B)(4) 2013 - LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM DISCOMFORT, INFLAMMATION, DIFFICULTY AMBULATING, CLICKING/POPPING, METALLOSIS, AND INFECTION. ALL PRODUCTS HAVE BEEN REPORTED AND INITIAL EMDRS CREATED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    65176 PINNACLE SECTOR II CUP 56MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US DW1HK1000

    Patients

    Seq Age Sex Outcome Treatment
    1 66 YR Required Intervention