BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LCP DHS PLATE 135 DEGREE, 4 HOLES,38/92MM STAINLESS STEEL

    MDR report key: 3222687 · Received July 12, 2013

    Report

    Report Number
    2520274-2013-04228
    Event Type
    Injury
    Date Received
    July 12, 2013
    Report Date
    June 19, 2013
    Manufacturer
    SYNTHES GMBH
    Product Code
    KTT
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    SZ
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. THIS REPORT IS FOR AN UNKNOWN DHS IMPLANT. DEVICE WAS IMPLANTED 1.5 YEARS PRIOR TO EXPLANT. WITHOUT A LOT NUMBER, THE DEVICE HISTORY RECORDS REVIEW COULD NOT BE COMPLETED. THE INVESTIGATION COULD NOT BE COMPLETED; NO CONCLUSION COULD BE DRAWN, AS NO PRODUCT WAS RECEIVED.

    Additional Manufacturer Narrative · 1

    THIS DEVICE IS USED FOR TREATMENT, NOT DIAGNOSIS. ADDITIONAL NARRATIVE INVESTIGATION COORDINATED BY SYNTHES (B)(4). REPORT RECEIVED INDICATES THE MEASURABLE DIMENSIONS OF THE RETURNED IMPLANT WERE CHECKED AND FOUND TO CHECKED AND FOUND TO BE IN COMPLIANCE WITH THE TECHNICAL DRAWINGS AND AO/ASIF SPECIFICATION. EXAMINATION OF THE RAW MATERIAL TESTING CERTIFICATES AND THE MANUFACTURING RECORDS SHOWED NO DEVIATIONS REGARDING MATERIAL ANALYSIS, STRENGTH AND STRUCTURAL STABILITY. THE VALUES WERE IN COMPLIANCE WITH AO/ASIF SPECIFICATION AND WITH THE INTERNATIONAL STANDARD. NO MANUFACTURING RELATED ISSUES THAT WOULD HAVE CONTRIBUTED TO THIS COMPLAINT WERE FOUND. CORROSION MARKS/FRETTING CORROSION WERE OBSERVED AT THE NON-THREADED PORTION OF THE PLATE HOLES. THE CORROSION RESULTS FROM MICROMOVEMENTS BETWEEN THE SCREW HEAD AND THE PLATE. THE MICROMOVEMENTS CAUSED DAMAGE TO THE PASSIVATION LAYER OF THE METAL AND PANDERS FRETTING CORROSION.

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. MANUFACTURER DETERMINED FROM RECEIPT OF LOT NUMBER. PRODUCT RECEIVED 08/06/2013. 510(K): DEVICE IS NOT DISTRIBUTED IN THE UNITED STATES BUT IS SIMILAR TO A DEVICE MARKETED IN THE UNITED STATES. 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 WAS PERFORMED AND NO COMPLAINT RELATED ISSUES WERE FOUND. MANUFACTURE DATE DETERMINED FROM REVIEW OF DEVICE HISTORY RECORDS.

    Description of Event or Problem · 1

    DEVICE REPORT FROM SYNTHES (B)(4) REPORTS AN EVENT IN (B)(6) AS FOLLOWS: THE DYNAMIC HIP SYSTEM (DHS) WAS IMPLANTED 1.5 YEARS AGO. AFTER 1.5 YEARS THE IMPLANT WAS REMOVED DUE TO PATIENT PAIN. RUST WAS OBSERVED ON THE DHS IMPLANT AT THE TIME OF REMOVAL. THERE WAS NO PATIENT INFECTION. THIS PATIENT ALSO HAD A DISTAL TIBIA PLATE. THIS IMPLANT WAS REMOVED ON THE SAME DAY, AND DID NOT SHOW CORROSION. THIS REPORT IS FOR AN UNKNOWN DHS IMPLANT. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    321919 LCP DHS PLATE 135 DEGREE, 4 HOLES,38/92MM STAINLESS STEEL KTT SYNTHES GMBH 7722286

    Patients

    Seq Age Sex Outcome Treatment
    1 48 YR Required Intervention