BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ2 HI OFF

    MDR report key: 4853216 · Received June 18, 2015

    Report

    Report Number
    1818910-2015-23899
    Event Type
    Injury
    Date Received
    June 18, 2015
    Date of Event
    May 23, 2014
    Report Date
    May 28, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. BASED ON PREVIOUS INVESTIGATIONS THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. 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. 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

    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 ALLEGES THE PATIENT SUFFERS FROM DISLOCATION, PAIN, DIFFICULTY AMBULATING, AND METAL POISONING. UPDATE 5/28/2015 - PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED PAIN, SQUEAKING, DISLOCATIONS, INCREASED METAL IONS (NO LABS), MILD METALLOSIS, AND NOTCHING ON THE FEMORAL NECK (RELATED TO DISLOCATIONS). NO IMPINGEMENT NOTED. THE STEM IS BEING ADDED AND PART/LOT IS BEING UPDATED. THE COMPLAINT WAS UPDATED ON:6/18/2015.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    396534 SUMMIT POR TAPER SZ2 HI OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US DE5CA1000

    Patients

    Seq Age Sex Outcome Treatment
    1 77 YR Required Intervention