BEUDAMED
    FDA Adverse Event Injury Summary report: N

    UNKNOWN ANKLE TALAR

    MDR report key: 9483060 · Received December 17, 2019

    Report

    Report Number
    1818910-2019-119787
    Event Type
    Injury
    Date Received
    December 17, 2019
    Date of Event
    June 1, 2013
    Report Date
    November 19, 2019
    Manufacturer
    DEPUY ORTHOPAEDICS INC US
    Product Code
    HSN
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    DEPUY SYNTHES IS SUBMITTING THIS REPORT PURSUANT TO THE PROVISION OF 21 CFR, PART 803. THE REPORT MAY BE BASED ON THE INFORMATION WHICH DEPUY SYNTHES HAS NOT BEEN ABLE TO INVESTIGATE OR VERIFY PRIOR TO THE REQUIRED REPORTING DATE. THIS REPORT DOES NOT REFLECT A CONCLUSION BY FDA, DEPUY SYNTHES OR ITS EMPLOYEES THAT THE REPORT CONSTITUTES AN ADMISSION THAT THE DEVICE, DEPUY SYNTHES, OR ITS EMPLOYEES CAUSED OR CONTRIBUTED TO THE POTENTIAL EVENT DESCRIBED IN THIS REPORT. PRODUCT COMPLAINT # (B)(4). INVESTIGATION SUMMARY : NO DEVICE ASSOCIATED WITH THIS REPORT WAS RECEIVED FOR EXAMINATION. A WORLDWIDE LOT SPECIFIC COMPLAINT DATABASE SEARCH, OR DEVICE HISTORY RECORD (DHR) REVIEW, WAS NOT POSSIBLE BECAUSE THE REQUIRED LOT NUMBER WAS NOT PROVIDED. BASED ON PREVIOUS INVESTIGATIONS, THIS COMPLICATION OF JOINT REPLACEMENT IS UNLIKELY TO HAVE BEEN THE RESULT OF A DEVICE FAILING TO MEET REQUIRED SPECIFICATIONS. THE INFORMATION RECEIVED WILL BE RETAINED FOR POTENTIAL SERIES INVESTIGATIONS IF TRIGGERED BY TREND ANALYSIS, POST MARKET SURVEILLANCE, OR OTHER EVENTS WITHIN THE QUALITY SYSTEM. IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE.

    Additional Manufacturer Narrative · 1

    (B)(4). IF INFORMATION IS OBTAINED THAT WAS NOT AVAILABLE FOR THE INITIAL MEDWATCH, A FOLLOW-UP MEDWATCH WILL BE FILED AS APPROPRIATE. (B)(4).

    Description of Event or Problem · 1

    THE LITERATURE ARTICLE ENTITLED "TOTAL ANKLE ARTHROPLASTY: A RADIOGRAPHIC OUTCOME STUDY¿ WRITTEN BY AMIE Y. LEE, ET AL, PUBLISHED IN AMERICAN JOURNAL OF ROENTGENOLOGY IN JUNE 2013; WAS REVIEWED. THE PURPOSE OF THIS STUDY WITHIN THE ARTICLE WAS TO DETERMINE THE RADIOGRAPHIC OUTCOME OF TAA¿S AND TO CORRELATE THIS WITH CLINICAL OUTCOME. FROM JANUARY 2003 TO DECEMBER 2011, 118 ANKLE ARTHROPLASTIES WERE PERFORMED IN 116 PATIENTS AT PENNSYLVANIA STATE UNIVERSITY MEDICAL CENTER. FROM JANUARY 2005 TO FEBRUARY 2010, 149 ANKLE ARTHROPLASTIES WERE PERFORMED IN 149 PATIENTS AT HARBORVIEW MEDICAL CENTER, UNIVERSITY OF WASHINGTON. THUS, A TOTAL OF 262 ANKLE ARTHROPLASTIES IN 260 PATIENTS WERE REVIEWED. THERE WERE 197 AGILITY IMPLANTS (DEPUY) AND TWO OTHER NON-DEPUY IMPLANTS USED IN THE STUDY. SYNDESMOTIC FUSION WAS PERFORMED WITH ALL AGILITY IMPLANTS. RADIOGRAPHIC COMPLICATIONS AFTER TAA FOR THE AGILITY IMPLANT ARE AS FOLLOWS: PERIHARDWARE LUCENCY, SUBSIDENCE, PERHARDWARE FRACTRUES, SYNDESMOTIC LOOSENING, HARDWARE FRACTURE, HETEROTOPIC OSSIFICATION, INCREASED VARUS OR VALGUS ANKLE, ANKLE GUTTER NARROWING AND SYNDESMOTIC NONUNION OR FRACTURE. THE ARTICLE ALSO REPORTS THAT 119 PATIENTS EVENTUALLY DEVELOPED SYMPTOMS OF ANKLE PAIN OR INSTABILITY. 71 PATIENTS ALSO REQUIRED AT LEAST ONE ADDITIONAL SURGERY THAT INCLUDED 17 ANKLE DEBRIDEMENT¿S OR ARTHROTOMIES, 13 SCREW PLATE REMOVALS, 11 SYNDESMOTIC FUSION REVISIONS, 19 ANKLE ARTHROPLASTY REVISIONS (DEFINED AS POLYETHYLENE OR METALLIC COMPONENT REPLACEMENT), EIGHT REALIGNMENT OSTEOTOMIES, TWO TOTAL ANKLE JOINT FUSIONS, SIX BONE GRAFTS FOR PERIPROSTHETIC LUCENCIES OR CYSTS, AND TWO ABSCESS IRRIGATIONS. OVERALL, COMPLICATION RATES WERE SIMILAR BETWEEN THE TWO INSTITUTIONS. THE AUTHORS DO NOT SPECIFY WHICH IMPLANTS REQUIRED THE ADDITIONAL SURGERIES. IT IS NOT NOTED WHO THE MANUFACTURER OF THE HARWARE MENTIONED IN THE ARTICLE BELONGS TO, THEREFORE IT WILL NOT BE REPORTED UPON.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1272500 UNKNOWN ANKLE TALAR UNKNOWN ANKLE TALAR HSN DEPUY ORTHOPAEDICS INC US

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention