BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3813103 · Received May 15, 2014

    Report

    Report Number
    2520274-2014-11198
    Event Type
    Injury
    Date Received
    May 15, 2014
    Report Date
    April 24, 2014
    Manufacturer
    SYNTHES(USA)
    Product Code
    HRS
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. BAE, D.K., SONG, S.J., YOON, K.H., AND KIM, T.Y. (2013). PERIPROSTHETIC SUPRACONDYLAR FEMORAL FRACTURES ABOVE TOTAL KNEE ARTHROPLASTY: COMPARISON OF THE LOCKING AND NON-LOCKING PLATING METHODS. KNEE SURG SPORTS TRAUMATOL ARTHROSC, DOI 10.1007/S00167-013-2572-2. THIS REPORT IS FOR AN UNKNOWN PLATE. 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. 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

    THIS REPORT IS BEING FILED AFTER SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, BAE, D.K., SONG, S.J., YOON, K.H., AND KIM, T.Y. (2013). PERIPROSTHETIC SUPRACONDYLAR FEMORAL FRACTURES ABOVE TOTAL KNEE ARTHROPLASTY: COMPARISON OF THE LOCKING AND NON-LOCKING PLATING METHODS. KNEE SURG SPORTS TRAUMATOL ARTHROSC, DOI 10.1007/S00167-013-2572-2. THE AUTHORS CONDUCTED A RETROSPECTIVE STUDY TO COMPARE THE RESULTS AND COMPLICATIONS OF PERIPROSTHETIC SUPRACONDYLAR FEMORAL FRACTURE TREATMENT USING LOCKING OR NON-LOCKING PLATES. THIRTY-TWO PATIENTS (33 FRACTURES) WHO WERE TREATED BETWEEN 1997 AND 2011 WERE INCLUDED IN THE STUDY AND FOLLOWED UP FOR A MINIMUM OF 12 MONTHS POSTOPERATIVELY. FOURTEEN PATIENTS (12 FEMALE, TWO MALE, AVERAGE AGE 67 YEARS) WERE TREATED WITH A SYNTHES LOCKING COMPRESSION PLATE AND 19 PATIENTS WERE TREATED WITH A NON-LOCKING CONDYLAR BUTTRESS PLATE. THIRTEEN OF THE 14 LOCKING PLATE FIXED FRACTURES HEALED WITHOUT ANY ADDITIONAL SURGERIES. ONE OF THE LOCKING PLATE FIXED FRACTURES DEVELOPED A NON-UNION LEADING TO HARDWARE FAILURE. IT WAS SUCCESSFULLY TREATED WITH REVISION OPEN REDUCTION INTERNAL FIXATION (ORIF) WITH AUTOGENOUS AND ALLOGENOUS CANCELLOUS BONE GRAFTS. THE AUTHORS CONCLUDED THAT FIXATION OF PERIPROSTHETIC SUPRACONDYLAR FEMORAL FRACTURES WITH A LOCKING PLATE PROVIDED SATISFACTORY RESULTS WITH A LOW RISK OF COMPLICATIONS AND ADDITIONAL SURGERIES COMPARED WITH FIXATION WITH A NON-LOCKING PLATE. THIS IS REPORT 1 OF 1 FOR COMPLAINT (B)(4). THIS REPORT IS FOR AN UNKNOWN PLATE. A COPY OF THE JOURNAL ARTICLE IS BEING SUBMITTED WITH THIS MEDWATCH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    291263 PLATE, FIXATION, BONE HRS SYNTHES(USA)

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention