BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 11/13 36 +3

    MDR report key: 3367591 · Received September 25, 2013

    Report

    Report Number
    1818910-2013-28499
    Event Type
    Injury
    Date Received
    September 25, 2013
    Date of Event
    May 21, 2012
    Report Date
    October 18, 2012
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. 1818910
    Product Code
    JDI
    PMA / PMN Number
    K082585
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE 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

    ADDITIONAL NARRATIVE: THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 3104373, 3009476, 3104369, AND 3000266 DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. MEDICAL RECORDS AND XRAYS WERE RECEIVED AND REVIEWED. FROM THE INFORMATION REVIEWED IN THIS REPORT IT IS UNLIKELY THAT THERE WAS A MANUFACTURING FAULT. 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 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 (B)(4). REASON FOR ORIGINAL COMPLAINT.- BILATERAL PATIENT. LITIGATION ALLEGES THAT PATIENT HAS EXPERIENCED PAIN, DIFFICULTY WALKING, CONTINUED SWELLING, AND NERVE DAMAGE. DOI: (B)(6) 2010 - DOR: NONE REPORTED (BOTH SIDES). PATIENT IS A RESIDENT OF (B)(6). UPDATE: (B)(6) 2012 - PFS WAS RECEIVED FROM LEGAL, MEDICAL RECORDS WERE RECEIVED FROM LEGAL, AND PART/LOT INFORMATION WAS IDENTIFIED. RECORDS ARE AVAILABLE FOR FURTHER REVIEW.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    484670 ASPHERE M SPEC 11/13 36 +3 FEMORAL HEAD JDI DEPUY ORTHOPAEDICS, INC. 1818910 3000266

    Patients

    Seq Age Sex Outcome Treatment
    1 55 YR Other