BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ4 HI OFF

    MDR report key: 3991203 · Received August 8, 2014

    Report

    Report Number
    1818910-2014-25268
    Event Type
    Injury
    Date Received
    August 8, 2014
    Date of Event
    June 6, 2013
    Report Date
    July 24, 2014
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THIS 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

    PRODUCT COMPLAINT # (B)(4).

    Description of Event or Problem · 1

    LITIGATION ALLEGES THE PATIENT SUFFERS FROM FLUID COLLECTION CONSISTENT WITH A PSEUDOTUMOR, METALLOSIS, POTENTIAL TRUNNIONOSIS AND CHRONIC INFLAMMATION SUGGESTIVE OF ALVAL. UPDATE REC'D (B)(4) 2014-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THERE WAS CORROSION NOTED ON THE TRUNNION. THE STEM IS NOW BEING ADDED. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING MDR DECISION. THE COMPLAINT WAS UPDATED ON: (B)(4) 2014.

    Description of Event or Problem · 1

    PPF ALLEGES ABDUCTOR MUSCLE REPAIR, INFECTION, ELEVATED METAL IONS AND METAL WEAR. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED DUE TO PAIN AND FAILED HIP ARTHROPLASTY. OPERATIVE NOTES DID NOT MENTION ANY INFECTION AS PPF ALLEGED. NO LAB RESULT WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    467761 SUMMIT POR TAPER SZ4 HI OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS INC US CL3ES1000

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR