BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX25MM

    MDR report key: 4864006 · Received June 23, 2015

    Report

    Report Number
    1818910-2015-24186
    Event Type
    Injury
    Date Received
    June 23, 2015
    Date of Event
    May 7, 2013
    Report Date
    May 29, 2015
    Manufacturer
    1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC
    Product Code
    LPH
    PMA / PMN Number
    PK983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Additional Manufacturer Narrative · 1

    NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. IN ORDER TO DETERMINE IF A LOT RELATED ISSUE WAS POSSIBLE, A WORLDWIDE COMPLAINT DATABASE SEARCH WAS PERFORMED. THE COMPLAINT DATABASE SEARCH IDENTIFIED A PREVIOUS RELATED REPORT AGAINST LOT(S) C5ERG4000. REVIEW OF DEVICE HISTORY RECORDS FINDS NO RELATED MANUFACTURING DEVIATIONS OR ANOMALIES THAT WOULD HAVE CONTRIBUTED TO THE REPORTED EVENT. A WORLDWIDE COMPLAINT DATABASE SEARCH FOUND NO ADDITIONAL RELATED REPORTS AGAINST THE PROVIDED PRODUCT CODE/LOT CODE COMBINATION(S). MEDICAL RECORDS WERE RECEIVED AND REVIEWED. THE INVESTIGATION CAN DRAW NO CONCLUSIONS WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO DETERMINE A ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION HAS NOT BEEN 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.

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

    Description of Event or Problem · 1

    LITIGATION ALLEGES THAT THE PATIENT SUFFERS FROM PAIN, DISCOMFORT AND LARGE AMOUNTS OF TOXIC COBALT CHROMIUM METAL ION PARTICLES TO BE RELEASED INTO THE BLOOD, TISSUE, AND BONE. UPDATE 5/29/15-PFS AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, THE REVISION OPERATIVE NOTE INDICATED LOOSE CUP, WEAR DEBRIS, METALLOSIS, LOOSE LINER FROM THE CUP, GREATER TROCHANTER AVULSION FRACTURE THAT WAS CABELED, AND PAIN. THE CAUSE/TIME OF THE FRACTURE IS UNKNOWN. THE STEM WAS NOTED TO BE LOOSE AND STABLE, BUT WASN'T REVISED. NO LABS WERE PROVIDED FOR THE ALLEGED HIGH METAL IONS. THE STEM, CUP, AND 5 SCREW ARE BEING ADDED TO THE COMPLAINT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    404763 PINN CAN BONE SCREW 6.5MMX25MM HIP OTHER IMPLANT LPH 1219655 DEPUY-RAYNHAM, A DIV. OF DEPUY ORTHOPAEDIC C99AE4000

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Required Intervention