BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 HI OFF

    MDR report key: 4671585 · Received April 9, 2015

    Report

    Report Number
    1818910-2015-18067
    Event Type
    Injury
    Date Received
    April 9, 2015
    Date of Event
    October 9, 2012
    Report Date
    March 31, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.1818910
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. A SEARCH OF THE COMPLAINT DATABASE FOUND NO ADDITIONAL REPORTS FOR THE LOT CODES 1890628, 1877987, AND 1894677. A SEARCH OF THE COMPLAINT DATABASE SEARCH FINDS THREE ADDITIONAL REPORTED INCIDENTS AGAINST LOT CODE 1914171 SINCE ITS RELEASE FOR DISTRIBUTION; HOWEVER, A PREVIOUS REVIEW OF THE DEVICE HISTORY RECORD DID NOT REVEAL ANY RELATED MANUFACTURING ANOMALIES. MEDICAL RECORDS WERE REVIEWED. 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 STILL 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.

    Additional Manufacturer Narrative · 1

    THIS COMPLAINT IS STILL UNDER INVESTIGATION. DEPUY WILL NOTIFY THE FDA OF THE RESULTS OF THIS INVESTIGATION ONCE IT HAS BEEN COMPLETED. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    LITIGATION PAPERS ALLEGE THE PATIENT SUFFERS FROM PERSISTENT SEVERE PAIN, DISCOMFORT, WEAKNESS, DECREASED RANGE OF MOTION, DIFFICULTY WITH ACTIVITIES OF DAILY LIVING, AND ELEVATED AND POTENTIAL TOXIC CHROMIUM AND COBALT METAL IONS IN THE BLOODSTREAM. UPDATE 3/31/2015 -PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE FOR THE LEFT HIP INDICATED SUBLUXATION AND DISLOCATIONS. THERE WAS SOME SCUFFING NOTED ON THE FEMORAL HEAD. ONLY THE FEMORAL HEAD ON THE LEFT HIP WAS REVISED. THE STEM FOR THE LEFT HIP IS BEING ADDED TO THE COMPLAINT FOR THE ALLEGED HIGH METAL IONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    235245 SUMMIT POR TAPER SZ6 HI OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC.1818910 ZP5CV1000

    Patients

    Seq Age Sex Outcome Treatment
    1 64 YR Other