BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ASPHERE M SPEC 12/14 36 +1.5

    MDR report key: 3130656 · Received May 24, 2013

    Report

    Report Number
    1818910-2013-17665
    Event Type
    Injury
    Date Received
    May 24, 2013
    Date of Event
    April 17, 2017
    Report Date
    May 14, 2013
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    JDI
    PMA / PMN Number
    PK082585
    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

    THE DEVICE ASSOCIATED WITH THIS REPORT WAS NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE AND/OR DHR REVIEW WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODE REQUIRED WAS NOT PROVIDED. THE INVESTIGATION COULD NOT DRAW ANY CONCLUSIONS REGARDING THE REPORTED EVENT WITH THE INFORMATION AVAILABLE. 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

    (B)(4). THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR LOT CODES 3167107 AND 3115769 DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE PART AND LOT CODE COMBINATION WAS NOT PROVIDED FOR THE UNKNOWN DEPUY DEVICE. 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

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY: NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT, INFLAMMATION, SWELLING, IMPLANT LOOSENING AND DIFFICULTY AMBULATING.

    Description of Event or Problem · 1

    PPF AND STICKER SHEETS RECEIVED. THERE ARE NO NEW ALLEGATIONS REPORTED. DOR WAS UPDATED TO (B)(6) 2017. DOI: (B)(6) 2011 - DOR: (B)(6) 2017 (RIGHT HIP).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    232480 ASPHERE M SPEC 12/14 36 +1.5 TOTAL HIP REPLACEMENT JDI DEPUY ORTHOPAEDIC INC, 1818910 3115769

    Patients

    Seq Age Sex Outcome Treatment
    1 Other