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

Catalog Number UNK ANKLE TALAR

Device Problem Device Dislodged or Dislocated (2923)

Patient Problems Bone Fracture(s) (1870); Pain (1994); Joint Dislocation (2374); No Code Available (3191)

Event Date 01/01/2013

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 ¿use of femoral locking plate for salvage of failed ankle arthroplasty after trauma¿ written by lawrence a.Didomenico, dpm, facfas, et al; published in the journal of foot and ankle surgery, in 2013, 52, 397-401; was reviewed.This article reports on a case study of a (b)(6) year old woman with a medical history of gout, cancer, heart disease, hypertension, foot and leg cramping, varicose veins and post-traumatic arthritis presented with a chief chronic complaint of ankle pain that had worsened during a six-month period.She related a vast history or fractures and recurrent sprains to her left ankle.Conservative measures were attempted for two years until she finally underwent a total ankle prosthesis, agility, lp total ankle system (depuy), gastrocnemius recession, and midfoot fusion.The patient experienced a stable, non-symptomatic pseudo-arthritis of the tibiofibular joint.This construct proved to be satisfactory for five years, until the patient fell down the steps.After the accident, radiographs revealed the talar component had been anteriorly displaced and rotated.The pseudo-arthritis demonstrated no changes, widening or instability; thus it was believed to be unrelated to the trauma.The patient also showed signs of tenderness and swelling of the left ankle.She was pain free with rom to the subtalar joint.An attempted revision proved to not be possible, and the total ankle arthroplasty was removed, and ankle fusion was performed using an anterior ankle arthrodesis locking plate (manufacturer not specified).

Manufacturer Narrative

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.Additional narrative: product complaint # (b)(4).Investigation summary: no device associated with this report was received for examination.Visual examination of the provided x-ray images confirmed the reported event.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.

• 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: 9428469
• MDR Text Key: 185235835
• Report Number: 1818910-2019-121636
• 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: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 11/14/2019

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: 11/14/2019
• Initial Date FDA Received: 12/06/2019
• Supplement Dates Manufacturer Received: 01/06/2020
• Supplement Dates FDA Received: 01/07/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention