MAUDE Adverse Event Report: DEPUY ORTHOPAEDICS INC US UNKNOWN ANKLE TALAR

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%.

• Brand Name: UNKNOWN ANKLE TALAR
• Type of Device: ANKLE TALAR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• Manufacturer (Section G): JTE WARSAW MFG SITE; 700 orthopaedic drive; warsaw IN 46582
• Manufacturer Contact: kara ditty-bovard ; 1210 ward avenue; west chester, IN 46581-0988 ; 6103142063
• MDR Report Key: 9468033
• MDR Text Key: 185342269
• Report Number: 1818910-2019-121211
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• 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 Received: 12/13/2019
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: UNK ANKLE TALAR
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/08/2020
• 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 Sequence Number: 1
• Patient Outcome(s): Required Intervention