• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services


  • Print
  • Share
  • E-mail
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC

Catalog Number UNK ANKLE TALAR
Device Problems Loss of or Failure to Bond (1068); Migration (4003)
Patient Problems Unspecified Infection (1930); Pain (1994); Inadequate Osseointegration (2646); No Code Available (3191)
Event Date 12/04/2013
Event Type  Injury  
Manufacturer Narrative
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. 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.
Manufacturer Narrative
(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).
Event Description
The literature article entitled " management of failures of total ankle replacement with the agility total ankle arthroplasty¿ written by j. Kent ellington, md, ms, et al; published in the journal of bone and joint surgery, volume 95-a, number 23, december 4, 2013; was reviewed. The purposes of the study within the article were to retrospectively review the outcomes of patients who underwent revision total ankle replacement and to provide a talar subsidence grading system that can be used as a guide for revision arthroplasty. Between january 2002 and july 2008, at the institute for foot and ankle reconstruction at mercy medical center in baltimore, maryland, 53 patients underwent revision total ankle replacement requiring a component exchange. In 52 of the primary arthroplasties, the agility prosthesis (depuy) was used. All the patients who underwent a revision of the procedure requiring removal of either the tibial or the talar component (due to aseptic loosening), followed by insertion of a revision prosthesis. Five of the 53 patients were lost to follow up and seven additional patients declined to participate due to lengthy travel. In addition, five other patients had undergone implant removal and conversion to a tibiotalocalcaneal arthrodesis (as a result of subsidence of tibial and talar components in one patient, talar component subsidence in two patients, loosening of the tibial component in one patient, and fibular fracture and tibial component subsidence in one patient. Three of the five arthrodesis were performed after a failed second revision total ankle replacement. Two other patients had undergone a below-the-knee amputation to treat a chronic infection. Both amputations were also performed after a second revision total ankle replacement. As a result, 41 patients were available for complete radiographic and clinical follow-up with retained components and seven additional patients with an arthrodesis or below the knee amputation. At final follow-up, 16 of the 41 patients demonstrated evidence of tibial subsidence and 15 of the 41 patients demonstrated evidence of talar subsidence; 23 underwent subtalar arthrodesis at the time of revision arthroplasty. 15 of the 41 patients underwent revision of the talar component only, and no patient underwent an isolated revision of the tibial component only. 26 of the 41 patients underwent revision of both the tibial and talar components. 19 patients required a custom talar component as a result of talar subsidence, and one patient required a custom tibial component as a result of tibial subsidence. In five patients, the revision arthroplasty failed and a second revision was performed. All five of the second revisions failed due to talar subsidence, pain with arthrofibrosis and infection. Lucency was identified in 40 of the 41 prosthesis on final radiograph. The article identifies talar subsidence as the most common reason for revision at 63%, loosening and/or migration at 29%, and other reasons at 5%.
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Type of DeviceANKLE TALAR
Manufacturer (Section D)
700 orthopaedic drive
warsaw IN 46581 0988
Manufacturer (Section G)
700 orthopaedic drive
warsaw IN 46582
Manufacturer Contact
kara ditty-bovard
1210 ward avenue
west chester, IN 46581-0988
MDR Report Key9468033
MDR Text Key185342269
Report Number1818910-2019-121211
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 11/19/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/13/2019
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberUNK ANKLE TALAR
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/08/2020
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/13/2019 Patient Sequence Number: 1