BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINNACLE SECTOR II CUP 54MM

    MDR report key: 3221399 · Received July 11, 2013

    Report

    Report Number
    1818910-2013-21002
    Event Type
    Injury
    Date Received
    July 11, 2013
    Date of Event
    April 20, 2011
    Report Date
    June 17, 2013
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    KWA
    PMA / PMN Number
    PK082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, 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 LOT CODES 2765323 AND C31EA1000. A SEARCH OF THE COMPLAINT DATABASE FINDS ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODES 2772133, 2812869, AND 2673247 SINCE THEIR RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS 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. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER WPC (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION PAPERS ALLEGE: AGONIZING PAIN IN HIS GROIN, HIS INNER THIGH, AND HIS BUTTOCKS AREA AND HAD SEVERE DIFFICULTY WALKING OR MOVING IN GENERAL. DOI: (B)(6) 2008 LEFT HIP, DOR: (B)(6) 2011. DOI: (B)(6) 2009 RIGHT HIP, DOR: NONE REPORTED. PATIENT RESIDENCE: (B)(6). UPDATE: (B)(4) 2012, PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE EXISTING MDR DECISION. RECORDS ARE AVAILABLE FOR FURTHER REVIEW. UPDATE: (B)(4) 2013 - UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, A MEDIAL FRACTURE WAS NOTED. THE ACETABULAR CUP HAS BEEN REPORTED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    320663 PINNACLE SECTOR II CUP 54MM ACETABULAR CUP KWA DEPUY ORTHOPAEDICS INC US C31EA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Other