BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLATE, FIXATION, BONE

    MDR report key: 3737333 · Received April 9, 2014

    Report

    Report Number
    2520274-2014-10577
    Event Type
    Injury
    Date Received
    April 9, 2014
    Date of Event
    May 26, 2013
    Report Date
    March 18, 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. THIS REPORT IS FOR 1 FAILED PLATE FIXATION DUE TO BROKEN PLATE. IMPLANT DATE AND EXPLANT DATE IS UNKNOWN. THE INVESTIGATION COULD NOT BE COMPLETED AND NO CONCLUSION COULD BE DRAWN AS NO DEVICE WAS RETURNED AND NO LOT NUMBER OR PART NUMBER WAS PROVIDED. 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. ARTHRODESIS OF THE KNEE FOLLOWING FAILED ARTHROPLASTY; P.J.H. VAN RENSCH; G.J. VAN DE POL; J.H.M. GOOSEN; A.B. WYMENGA; AND F.H.R. DE MAN; KNEE SURG SPORTS TRAUMATOL ARTHROSC DOI 10.1007/S00167-013-2539-3. THE ARTICLE WAS FROM (B)(6). THIS ARTICLE IS A RETROSPECTIVE STUDY OF PRIMARY STABILITY IN ARTHRODESIS OF THE KNEE FOLLOWING FAILED ARTHROPLASTY. THE PATIENTS WERE INCLUDED RETROSPECTIVELY WHEN THEY HAD A FAILED PRIMARY OR REVISION TOTAL KNEE ARTHROPLASTY (TKA) WITH AN INDICATION FOR ARTHRODESIS, PERFORMED IN THE PERIOD BETWEEN JANUARY 2004 AND MARCH 2012. THE FIXATION METHODS USED WERE INTRAMEDULLARY NAIL (IMN), BILATERAL PLATE FIXATION (LOCKING COMPRESSION PLATE [LCP]), AND MONOPLANE EXTERNAL FIXATOR. OF THESE 3 FIXATION METHODS, BILATERAL PLATE FIXATION (LCP) USED WAS MANUFACTURED BY SYNTHES, SOLOTHURN, SWITZERLAND. THE IMN AND MONOPLANE EXTERNAL FIXATOR WERE MANUFACTURED BY OTHER MANUFACTURERS. TWENTY-SIX (26) ARTHRODESES WERE PERFORMED. EIGHTEEN (18) PATIENTS WERE TREATED BECAUSE OF AN INFECTED ARTHROPLASTY. IN TOTAL, TEN (10) EXTERNAL FIXATORS, TEN (10) INTRAMEDULLARY NAILS AND SIX (6) PLATE FIXATIONS WERE APPLIED; SOLID FUSION WAS ACHIEVED IN 3/10, 8/10 AND 3/6, RESPECTIVELY. OF THESE 6 PLATE FIXATIONS, 3 WERE SUCCESSFUL AND 3 FAILED. OF THE 3 FAILED PLATE FIXATIONS, 2 FAILED DUE TO PERSISTING INFECTION AND 1 FAILED DUE TO BROKEN PLATE. OF THESE 3 FAILED PLATE FIXATION, 1 WAS REVISED TO IM NAIL, 1 WITH EXTERNAL FIXATION, AND 1 TO AMPUTATION. THIS IS REPORT 1 OF 2 FOR COMPLAINT (B)(4).

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    215296 PLATE, FIXATION, BONE HRS SYNTHES USA

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention