BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    LCP PROX-FEMPL 4.5/5 LE SHAFT 4HO L175 S

    MDR report key: 3187888 · Received June 25, 2013

    Report

    Report Number
    3003506883-2013-00271
    Event Type
    Malfunction
    Date Received
    June 25, 2013
    Report Date
    May 27, 2013
    Manufacturer
    SYNTHES ELMIRA
    Product Code
    HRS
    PMA / PMN Number
    K030858
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    ADDITIONAL NARRATIVE: AN INVESTIGATION WAS CONDUCTED AND IT STATES THAT THE MEASURABLE DIMENSIONS ARE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATIONS. THE EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATE AND THE MANUFACTURING PAPERS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES ARE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. NO PRODUCT FAULT COULD BE DETECTED. PLACEHOLDER.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. SUBJECT DEVICE HAS BEEN RECEIVED AND IS CURRENTLY IN THE EVALUATION PROCESS. INVESTIGATION IS ON GOING; NO CONCLUSION COULD BE DRAWN. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) REPORTS THE FOLLOWING: REVIEW OF FINISHED PRODUCT DEVICE HISTORY RECORD (PART NUMBER 242.104, LOT NUMBER 6772417, WORK ORDER 2779393, BRANCH PLANT 21) DETERMINED THAT THIS ORDER MET ALL DIMENSIONAL AND VISUAL CRITERIA AT THE TIME OF RELEASE, WITH NO IRREGULARITIES DOCUMENTED DURING MANUFACTURING THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THIS COMPLAINT CONDITION.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: IT WAS REPORTED PATIENT HAD DEVELOPED AN INFECTION AT THE IMPLANT AREA. PATIENT WAS OPERATED ON (B)(6) 2012, WITH AT FRACTURE AT THE PROXIMAL END OF THE LEFT FEMUR CAUSED BY A GUNSHOT. DURING A FOLLOW-UP VISIT ON (B)(6) 2013, THE PATIENT WAS DISCOVERED TO HAVE AN INFECTION AT THE ZONE OF THE IMPLANT OF THE PROXIMHI FEMORAL LCP PLATE, AND THE MEDICAL RECOMMENDATION WAS TO REMOVE THE BONE FIXATION MATERIAL. IT WAS ALSO REPORTED THE PATIENT HAD AN ABSCESSED CELLULITIS OF THE LEFT THIGH, WITH A RED AND HOT AREA, BUT WITH NO PAIN. NO FURTHER INFORMATION AVAILABLE AT THIS TIME. THIS IS 1 OF 1 DEVICE FOR THIS EVENT REPORTED ON COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    287812 LCP PROX-FEMPL 4.5/5 LE SHAFT 4HO L175 S HRS SYNTHES ELMIRA 6772417

    Patients

    Seq Age Sex Outcome Treatment
    1 22 YR