BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SUMMIT POR TAPER SZ7 HI OFF

    MDR report key: 4852314 · Received June 18, 2015

    Report

    Report Number
    1818910-2015-23876
    Event Type
    Injury
    Date Received
    June 18, 2015
    Report Date
    June 29, 2015
    Manufacturer
    DEPUY ORTHOPAEDICS, INC.
    Product Code
    LPH
    PMA / PMN Number
    PK001991
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    ATTORNEY

    Narratives

    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. 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

    IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. EXAMINATION OF THE REPORTED DEVICE WAS NOT POSSIBLE AS IT WAS NOT RETURNED. A SEARCH OF THE COMPLAINTS DATABASES IDENTIFIED NO OTHER REPORTS AGAINST THE PRODUCT AND LOT CODE COMBINATION. REVIEW OF PROVIDED MEDICAL RECORDS FINDS FROM A MEDICAL PERSPECTIVE, WITH THE VERY LIMITED AMOUNT OF MEDICAL RECORDS REVIEWED, IT IS NOT POSSIBLE TO DETERMINE IF THE COMPLAINT IS PRODUCT RELATED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN INDICATED.

    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 THE PATIENT SUFFERS FROM EXTREME PAIN, DISCOMFORT, SORENESS, MALAISE, SWELLING, IMMOBILIZATION AND BOTH ACUTE LOCALIZED DAMAGE TO TISSUE AND/OR BONE SURROUNDING THE ACETABULUM AND ELEVATED METAL ION LEVELS. UPDATE 1/7/13 - PPD RECEIVED. PART/LOT FOR THE RIGHT AND LEFT HIPS HAVE BEEN UDPATED. THERE IS NO NEW INFORMATION THAT WOULD CHANGE THE OUTCOME OF THE INVESTIGATION. UPDATE REC'D 6/1/2015 - MEDICAL RECORDS RECEIVED FOR RIGHT HIP REVISION FROM LEGAL. UPON REVISION, SYNOVITIS, OSTEOLYSIS AND CORROSION ON THE TRUNNION WERE NOTED. THE STEM REMAINED IN SITU. THE STEM AND SLEEVE ARE BEING ADDED TO THE COMPLAINT. THIS COMPLAINT WAS UPDATED ON 06/17/15.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    398581 SUMMIT POR TAPER SZ7 HI OFF HIP FEMORAL STEM/SLEEVE LPH DEPUY ORTHOPAEDICS, INC. A5ECT1000

    Patients

    Seq Age Sex Outcome Treatment
    1 Other