BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PINN CAN BONE SCREW 6.5MMX20MM

    MDR report key: 3875281 · Received June 16, 2014

    Report

    Report Number
    1818910-2014-21070
    Event Type
    Injury
    Date Received
    June 16, 2014
    Manufacturer
    DEPUY ORTHOPAEDIC INC, 1818910
    Product Code
    LPH
    PMA / PMN Number
    K983014
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    KS, 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. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    THE DEVICES ASSOCIATED WITH THIS REPORT WERE NOT RETURNED. REVIEW OF THE DEVICE HISTORY RECORDS AND/OR A COMPLAINT DATABASE SEARCH WAS NOT POSSIBLE AS THE PRODUCT AND LOT CODES REQUIRED WERE NOT PROVIDED. REQUESTS FOR ADDITIONAL INVESTIGATIONAL INPUTS WERE MADE IN ACCORDANCE WITH WI-7915 APPENDIX A. NO ADDITIONAL INFORMATION WAS OBTAINED. THE PATIENT WAS REPORTEDLY PRIMARILY IMPLANTED IN (B)(6) 2005 AND REVISED FOR LOOSENING SECONDARY TO INFECTION IN (B)(6) 2014. IT IS NOT LIKELY OR REASONABLE TO CONCLUDE THE DEPUY DEVICES CONTRIBUTED TO THE PATIENT'S REPORTED INFECTION MORE THAN SEVEN YEARS POST PRIMARY IMPLANTATION. THE INVESTIGATION COULD NOT VERIFY OR IDENTIFY ANY PRODUCT CONTRIBUTION TO THE REPORTED EVENT WITH THE INFORMATION PROVIDED. BASED ON THE INABILITY TO IDENTIFY ROOT CAUSE, THE NEED FOR CORRECTIVE ACTION WAS NOT INDICATED. DEPUY CONSIDERS THE INVESTIGATION CLOSED. SHOULD ADDITIONAL INFORMATION BE RECEIVED, THE INFORMATION WILL BE REVIEWED AND THE INVESTIGATION WILL BE RE-OPENED AS NECESSARY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    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 DEVELOPED SIGNIFICANT PAIN IN THE IMPLANTED HIP AND IS AT AN INCREASED RISK FOR REQUIRING REVISION SURGERY TO RESOLVE THE PATIENT'S PAIN. ADDITIONALLY IT IS ALLEGED THE PATIENT IS AT INCREASED RISK FOR SUFFERING FROM OR IN THE FUTURE DEVELOPING THE TOXIC EFFECTS OF THE COBALT AND CHROMIUM THAT HAVE DEGRADED FROM THE HIP IMPLANT INTO HIS BODY. **UPDATE RECEIVED (B)(4) 2014. THE SALES REP HAS REPORTED THE REVISION SURGERY. PATIENT WAS REVISED TO ADDRESS FEMORAL STEM LOOSENING AND INFECTION. IT IS REPORTED THAT THE LOOSENING WAS DUE TO THE INFECTION. *THIS COMPLAINT WAS UPDATED ON (B)(4) 2014

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    352608 PINN CAN BONE SCREW 6.5MMX20MM BONE SCREWS AND PINS : SCREWS LPH DEPUY ORTHOPAEDIC INC, 1818910 ZE4A34000

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention