BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ6 HI OFF

    MDR report key: 2991267 · Received March 6, 2013

    Report

    Report Number
    1818910-2013-04046
    Event Type
    Injury
    Date Received
    March 6, 2013
    Date of Event
    March 3, 2011
    Report Date
    July 25, 2016
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    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. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). 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

    ADDITIONAL NARRATIVE: 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 AT THIS TIME. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Description of Event or Problem · 1

    PATIENT WAS REVISED TO ADDRESS INFECTION. UPDATE (B)(4) 2013- LITIGATION PAPERS RECEIVED. THE MDR DECISION HAS BEEN REVERSED AND ALL PRODUCTS HAVE BEEN REPORTED.

    Description of Event or Problem · 1

    UPDATE -07/25/2016 PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IN ADDITION TO WHAT WAS PREVIOUSLY REPORTED, THE PFS REPORTS PAIN AND LIMITED ACTIVITIES. THE REVISION NOTES REPORTED METAL ION DEBRIS, METALLOSIS, AND BURNISHING ON THE TRUNNION OF THE STEM. MEDICAL RECORDS REPORT SEVERAL FALLS AND SLIGHTLY ELEVATED METAL ION LEVELS, BUT ALL THE LABS PROVIDED WERE AT NON-REPORTABLE LEVELS AND THE RESULTS OF CULTURES TAKEN DURING REVISION CAME BACK NEGATIVE FOR INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    96128 SUMMIT POR TAPER SZ6 HI OFF FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US BE9BS1000

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR Required Intervention