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

Catalog Number UNK ANKLE TALAR

Device Problem Loss of or Failure to Bond (1068)

Patient Problem No Code Available (3191)

Event Date 11/05/2014

Event Type  Injury  

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 "outcome of total ankle arthroplasty in patients with rheumatoid arthritis and noninflammatory arthritis¿, written by elizabeth pedersen, md, frcsc, et al; published in the journal of bone and joint surgery, volume 96-a, number 21, november 5, 2014; was reviewed."the purpose of this study was to compare the intermediate term clinical outcomes and safety of total ankle arthroplasty in patients with rheumatoid arthritis and a matched cohort of patients with noninflammatory arthritis undergoing the same procedure.Ankle joint replacement was performed using one of four prosthesis designs.The agility prosthesis (depuy) and the mobility prosthesis (depuy) were two of the four¿the other two were non-depuy products.From november 2001 to december 2008, 281 ankles (223 in the noninflammatory arthritis group and 58 in the rheumatoid arthritis group) underwent total ankle replacement.At the two-year follow-up evaluation, 267 ankles (211 and 50 ankles, respectively) were available for analysis.There were 10 patients with the mobility prosthesis and 11 with the agility prosthesis each in both the rheumatoid arthritis group and the noninflammatory arthritis group.Adverse events were associated with four (case 1, case 2, case 3 and case 7) of the 15 patients which are captured individually in linked complaints.There was also a patient with a mobility ankle prosthesis who underwent a skin graft due to superficial skin necrosis which was not directly related to the implant." this complaint captures case 2 which experienced aseptic loosening, components removed and conversion to arthrodesis.

Manufacturer Narrative

Depuy synthes is submitting this report pursuant to the provisions of 21 cfr, part 803.This report may be based on 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 : the device associated with this report was not received for examination.Depuy synthes considers the investigation closed at this time.Should additional information be received, the information will be reviewed and the investigation may be re-opened as necessary.If information is obtained that was not available for the initial medwatch, a follow-up medwatch, a follow-up medwatch will be filed as appropriate.

• Brand Name: UNKNOWN ANKLE TALAR
• Type of Device: ANKLE TALAR
• Manufacturer (Section D): DEPUY ORTHOPAEDICS INC US; 700 orthopaedic drive; warsaw IN 46581 0988
• MDR Report Key: 9428459
• MDR Text Key: 185545566
• Report Number: 1818910-2019-121620
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health professional,l
• Type of Report: Initial,Followup
• Report Date: 11/15/2019

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 11/15/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 02/03/2020
• Supplement Dates FDA Received: 02/04/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention