BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 58MM

    MDR report key: 2918037 · Received January 16, 2013

    Report

    Report Number
    1818910-2013-11031
    Event Type
    Injury
    Date Received
    January 16, 2013
    Report Date
    December 19, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    K073504
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. PATIENT SEEKING LEGAL ACTION. DOI: (B)(6) 2006; DOR: NONE REPORTED (LEFT HIP). UPDATE: (B)(4) 2013 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. THIS IS THE RIGHT HIP NOT LEFT. THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED AND ARE PRESUMED YET IMPLANTED. A COMPLAINT DATABASE SEARCH FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 2241090 SINCE ITS RELEASE FOR DISTRIBUTION. A REVIEW OF THE DEVICE HISTORY RECORDS DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. A COMPLAINT DATABASE SEARCH OF THE REMAINING LOT CODES FINDS NO ADDITIONAL REPORTS. A REVIEW OF THE PROVIDED PATIENT RECORDS DID NOT IDENTIFY A ROOT CAUSE. 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    PATIENT SEEKING LEGAL ACTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    24247 PINNACLE SECTOR II CUP 58MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US AC5CC1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other