BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3738755 · Received April 10, 2014

    Report

    Report Number
    2520274-2014-10703
    Event Type
    Malfunction
    Date Received
    April 10, 2014
    Report Date
    March 19, 2014
    Manufacturer
    SYNTHES (USA)
    Product Code
    HRS
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THIS DEVICE WAS USED FOR TREATMENT, NOT DIAGNOSIS. ALDRIAN, S. ET AL. (2013). FIXATION OF SUPRACONDYLAR FEMORAL FRACTURES FOLLOWING TOTAL KNEE ARTHROPLASTY: IS THERE ANY DIFFERENCE COMPARING ANGULAR STABLE PLATE FIXATION VERSUS RIGID INTERLOCKING NAIL FIXATION? ARCH ORTHOP TRAUMA SURG, 133, 921-927. THIS REPORT IS FOR AN UNKNOWN LESS INVASIVE STABILIZATION SYSTEM 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 THE SUBSEQUENT REVIEW OF THE FOLLOWING JOURNAL ARTICLE, ALDRIAN, S. ET AL. (2013). FIXATION OF SUPRACONDYLAR FEMORAL FRACTURES FOLLOWING TOTAL KNEE ARTHROPLASTY: IS THERE ANY DIFFERENCE COMPARING ANGULAR STABLE PLATE FIXATION VERSUS RIGID INTERLOCKING NAIL FIXATION? ARCH ORTHOP TRAUMA SURG, 133, 921-927. THE AUTHORS CONDUCTED A RETROSPECTIVE STUDY OF 86 PATIENTS (62 FEMALE AND 24 MALE; AVERAGE AGE: 75.6 YEARS) WITH SUPRACONDYLAR PERIPROSTHETIC FEMORAL FRACTURES BETWEEN 1996 AND 2010 TO COMPARE THE CLINICAL AND RADIOGRAPHIC OUTCOME AFTER ANGULAR STABLE PLATE FIXATION AND RIGID INTERLOCKING NAIL FIXATION OF SUPRACONDYLAR FEMORAL FRACTURES FOLLOWING TOTAL KNEE ARTHROPLASTY. FORTY EIGHT PATIENTS UNDERWENT IMPLANTATION OF ANGULAR STABLE PLATE DEVICES, SYNTHES LESS INVASIVE STABILIZATION SYSTEM PLATE (GROUP A); 38 PATIENTS UNDERWENT STABILIZATION WITH RIGID INTERLOCKING NAIL OF COMPETITOR (GROUP B). THE AUTHORS REPORTED THE FOLLOWING COMPLICATIONS IN GROUP A: NON-UNION WITH SEVERE MOTION PAIN AND SUBSEQUENT REVISION SURGERY WITH SUPPLEMENTAL BONE GRAFTING (SEVEN), THREE OF THE SEVEN PRESENTED WITH PLATE BREAKAGE PRIOR TO SURGERY; INCORRECT REDUCTION OR LACK OF REDUCTION (TWO); SECONDARY LOSS OF REDUCTION (THREE) AND IMPLANT FAILURE (THREE), FOUR OF WHICH REQUIRED REVISION SURGERY; WOUND INFECTION TREATED SUCCESSFULLY WITH ANTIBIOTIC THERAPY FOR SEVERAL DAYS (ONE); MAL POSITIONING OF PLATE AND SCREWS (ONE). THE AUTHORS CONCLUDED THAT INTRAMEDULLARY NAIL FIXATION SHOWED SLIGHT ADVANTAGES OVER LATERAL PLATE FIXATION. THIS IS A REPORTABLE MALFUNCTION REPORT FOR INCORRECT REDUCTION OR LACK OF REDUCTION (TWO) AND MAL POSITIONING OF PLATE AND SCREWS (ONE). THIS REPORT IS FOR AN UNKNOWN LESS INVASIVE STABILIZATION SYSTEM PLATE. THIS IS REPORT 3 OF 3 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    218305 PLATE, FIXATION, BONE HRS SYNTHES (USA)

    Patients

    Seq Age Sex Outcome Treatment
    1