BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ4 HI OFF

    MDR report key: 4886003 · Received July 1, 2015

    Report

    Report Number
    1818910-2015-24943
    Event Type
    Injury
    Date Received
    July 1, 2015
    Date of Event
    June 17, 2015
    Report Date
    June 17, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC. - 8010379
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SC, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    DEPUY STILL CONSIDERS THIS INVESTIGATION CLOSED AT THIS TIME.

    Additional Manufacturer Narrative · 1

    UPDATE 2/16/2016- SUPPLEMENTAL INFO RECEIVED. AFTER REVIEW OF THE SUPPLEMENTAL INFO FOR MDR REPORTABILITY, PART/LOT IS BEING UPDATED. THE COMPLAINT WAS UPDATED ON: 3/3/2016. (B)(4). SUMMIT POR TAPER SZ4 HI OFF, FDA CODE LPH, PART NUMBER: 157011100, LOT NUMBER:C1WED1000, K001991. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. THE ASR PLATFORM WAS VOLUNTARILY RECALLED FROM THE MARKET IN AUGUST 2010, AND THE ASR PRODUCT CODES ARE NOW CONSIDERED INACTIVE. FURTHER INVESTIGATION OF THIS INDIVIDUAL INCIDENT WILL NOT BE UNDERTAKEN, AS THERE IS AN ONGOING INVESTIGATION REGARDING THE ROOT CAUSE(S) AND/OR CORRECTIVE ACTIONS. (B)(4). DEPUY CONSIDERS THE INVESTIGATION CLOSED AT THIS TIME. SHOULD THE PRODUCT AND/OR ADDITIONAL INFORMATION BE RECEIVED, THE INVESTIGATION WILL BE RE-OPENED.

    Description of Event or Problem · 1

    UPDATE 1/20/16 MEDICAL RECORDS RECEIVED. MEDICAL RECORDS REVIEWED FOR MDR REPORTABILITY. REVISION SURGICAL NOTE REPORTED SYNOVITIS, LEG LENGTH DISCREPANCY WITH LEFT LONGER THAN RIGHT BY 1CM, BLOOD LOSS OF 550ML, ADHESIONS BETWEEN IT BAND AND TROCHANTERIC MUSCLES, AND FEMORAL NECK TO BE AT ABOUT 40 DEGREES OF ANTEVERSION WHICH WAS GREATER THAN NORMAL BUT STABLE AND NOT REVISED. NO STICKER SHEET OR COMPONENT LIST PROVIDED WITHIN MEDICAL RECORDS. THERE IS NO NEW ADDITIONAL INFORMATION THAT WOULD AFFECT THE EXISTING INVESTIGATION. THE COMPLAINT WAS UPDATED ON: FEB 8, 2016.

    Description of Event or Problem · 1

    UPDATE 2/16/2016- SUPPLEMENTAL INFO RECEIVED. AFTER REVIEW OF THE SUPPLEMENTAL INFO FOR MDR REPORTABILITY, PART/LOT IS BEING UPDATED. THE COMPLAINT WAS UPDATED ON:3/3/2016.

    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 ALLEGES THAT AFTER SURGERY, PATIENT BEGAN TO EXPERIENCE SEVERE PAIN AND SWELLING IN HER HIP. UPDATE REC'D 6/17/2015- SALES REP REPORTED REVISION SURGERY. HIP SIDE PROVIDED. PATIENT WAS REVISED TO ADDRESS HIGH CHROMIUM LEVELS. THE UNKNOWN HIP IS BEING CHANGED TO A CUP. HEAD, SLEEVE AND STEM ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON 07/01/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    429094 SUMMIT POR TAPER SZ4 HI OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. - 8010379 C1WED1000

    Patients

    Seq Age Sex Outcome Treatment
    1 53 YR Required Intervention