BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PRODIGY LG STAT LNG LT 16.5MM

    MDR report key: 3061565 · Received April 16, 2013

    Report

    Report Number
    1818910-2013-15442
    Event Type
    Injury
    Date Received
    April 16, 2013
    Date of Event
    January 6, 2013
    Report Date
    February 6, 2017
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LPH
    PMA / PMN Number
    K000207
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A REVIEW OF THE DEVICE HISTORY RECORDS FOR THE PROVIDED PRODUCT/LOT CODE COMBINATION DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. THE PRODUCT/LOT CODE COMBINATION WAS NOT PROVIDED FOR THE UNKNOWN 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 AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    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.

    Additional Manufacturer Narrative · 1

    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

    PATIENT WAS REVISED TO ADDRESS METAL TISSUE REACTION. UF RPT#490122-2013-0001, RECEIVED FROM HOSPITAL STATES THAT PATIENT WAS REVISED TO ADDRESS ELEVATED ION LEVELS AND FLUID COLLECTION AROUND THE HIP. UPDATE: (B)(6) 2013 - LITIGATION PAPERS RECEIVED. IT IS ALLEGED THAT THE PATIENT SUFFERS FROM PAIN, LOOSENING, AND METALLOSIS. AN UNKNOWN DEVICE HAS BEEN ADDED AND REPORTED TO ADDRESS LOOSENING.

    Description of Event or Problem · 1

    UPDATE 02/06/2017 ¿PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THE REVISION SURGERY NOTES REPORT PAIN, DISCOMFORT, ELEVATED METAL ION LEVELS, PSEUDOTUMOR AND CORROSION WAS NOTED AT THE DISTAL ASPECT OF THE TAPER ON THE FEMORAL STEM. METAL ION LEVELS PROVIDED WERE AT REPORTABLE LEVELS. CHANGING THE PREVIOUSLY UNKNOWN DEPUY COMPONENT TO A STEM AND ADDING PART/LOT. THE COMPLAINT WAS UPDATED ON: 02/15/2017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    163855 PRODIGY LG STAT LNG LT 16.5MM HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC.1818910 Y68BRC000

    Patients

    Seq Age Sex Outcome Treatment
    1 70 YR Required Intervention