BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ7 HI OFF

    MDR report key: 9210746 · Received October 18, 2019

    Report

    Report Number
    1818910-2019-110793
    Event Type
    Injury
    Date Received
    October 18, 2019
    Date of Event
    April 20, 2011
    Report Date
    September 23, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    LPH
    UDI-DI
    10603295060086
    PMA / PMN Number
    K001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY: 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. DEVICE HISTORY LOT : LOT C53KG1000. A REVIEW OF THE DEVICE MANUFACTURING RECORDS FOUND NO RELATED DEVIATIONS OR ANOMALIES. DEVICE HISTORY REVIEW : A REVIEW OF THE DEVICE MANUFACTURING RECORDS FOUND NO RELATED DEVIATIONS OR ANOMALIES.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). (B)(4). INITIAL REPORTER OCCUPATION: LAWYER. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. K001991.

    Description of Event or Problem · 1

    NEW ETQ RECORD CREATED IN ORDER TO UPDATE ETQ (LEGACY SYSTEM) COMPLAINT NUMBER (B)(4). REASON FOR ORIGINAL COMPLAINT. LITIGATION PAPERS ALLEGE: AGONIZING PAIN IN HIS GROIN, HIS INNER THIGH, AND HIS BUTTOCKS AREA AND HAD SEVERE DIFFICULTY WALKING OR MOVING IN GENERAL. DOI: (B)(6) 2008 LEFT HIP. DOR: (B)(6) 2011. DOI: (B)(6) 2009 RIGHT HIP. DOR: NONE REPORTED. UPDATE:6/17/2013 UPON MEDICAL RECORD REVIEW BY A MEDICAL PROFESSIONAL, A MEDIAL FRACTURE WAS NOTED. UPDATE: 08 AUG 2018 (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF PPF AND IMPLANT RECORDS. IN ADDITION TO WHAT PREVIOUSLY ALLEGED, PPF ALLEGES LOOSENING OF CUP, METAL WEAR, METALLOSIS AND ELEVATED METAL IONS. ALSO ADDED SCREW AND STEM IN IMPACTED PRODUCT DUE TO ALLEGED LOOSENING AND ELEVATED METAL IONS. DOI: (B)(4) 2008 DOR: (B)(4) 2011 LEFT HIP. SEE (B)(4) RIGHT HIP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1002995 SUMMIT POR TAPER SZ7 HI OFF SUMMIT HIP STEM : HIP FEMORAL STEM LPH DEPUY ORTHOPAEDICS INC US 1570-11-135 C53KG1000 10603295060086

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention