MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SALTO TALARIS IMPLANT - UNSPECIFIED; ANKLE REPLACEMENT

Catalog Number XXX-SALTO TALARIS IMPLANT

Device Problems Use of Device Problem (1670); Appropriate Term/Code Not Available (3191)

Patient Problems Failure of Implant (1924); Injury (2348); Impaired Healing (2378)

Event Type  Injury  

Manufacturer Narrative

The device involved in the reported incident is not available for evaluation.An investigation has been initiated based on the reported information.

Event Description

American orthopaedic foot & ankle society (2018) published ¿single-surgeon experience and complications of a fixed-bearing total ankle arthroplasty (taa)¿.This study aimed to retrospectively evaluate intra- and postoperative complications in 96 patients (104 total ankle arthroplasty) from a consecutive, single-surgeon population of primary salto talaris arthroplasty procedures, using radiographic analysis and medical records review to identify complications and the glazebrook classification system to categorize complications.Method: medical records from index procedure to latest follow-up of primary taa were reviewed.Complications were categorized according to the glazebrook classification; additional complications were documented.Concurrent procedures were recorded, and radiographs were analyzed for alignment, subsidence, and cyst formation.Time to complication onset and learning curve analyses were performed.One hundred four salto talaris taa prostheses (96 patients), with an average follow-up of 46 months, were included.Results: thirty-five complications were identified in 32 ankles with a 34% complication rate, resulting in 11 reoperations (5 taa revisions).Technical error (n = 12), wound healing (n = 9), and aseptic loosening (n = 4) were the most common complications, and there were no statistically significant differences in demographics or follow-up duration between cases with versus without complications.In both the cohorts with and without complications, there were moderate, negative correlations between radiographically observed keel osteopenia and lucency; also, in the complication cohort, a weak, positive correlation between subsidence and lucency was found.Conclusion: the 2-component salto talaris taa was an existing tool for the management of advanced ankle arthritis in a range of potential ankle arthroplasty candidates; however, few clinical reports and analyses of this specific implant existed.Two learning curve analyses highlighted the significance of technical expertise and annual volume of taa cases on complication rates.Implant survivorship and reoperation rate in this series were similar to previously reported early-term outcomes.The glazebrook classification of complication types in taa was applied to this series.A statistically significant correlation was found between radiographically observed lucency and ¿keel osteopenia¿ in both the cohorts, with and without complications.It may be possible to identify patients who are at increased risk for impending taa failure by documenting radiographic periprosthetic lucency, osteolysis, and cyst formation, thus allowing the clinician opportunities for more vigilant observation and follow-up.Event description for subject #13: - patient's age and gender ¿ (b)(6) y/o female.- bmi ¿ 28.2.- preoperative diagnosis - [left] advanced ankle arthritis s/p distal tibial resection, cavus foot - medical history - von willebrand disease, arthritis, thyroid disease, right hip implant, bilateral knee implants, right shoulder implant.- operative history - left ankle removal of bone.- concomitant procedure - tendo-achilles lengthening.- total follow-up (months) - 68.- complication type - technical error.- complication onset (months) - 0.- complication details - tibialis posterior tendon tear and planovalgus deformity; tibiotalar angle > 5 degrees.- complication treatment - total ankle arthroplasty revision, correction of planovalgus deformity, treatment of tibialis posterior tendon tear.- complication rating ¿ medium.

Manufacturer Narrative

The complaint device was not returned for evaluation.No lot information was provided; therefore, no dhr review can be performed.As no parts were returned, no failure analysis can be performed.The root cause for the reported event remains unknown.Attempts for additional information and product return have been unsuccessful to date.

• Brand Name: SALTO TALARIS IMPLANT - UNSPECIFIED
• Type of Device: ANKLE REPLACEMENT
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 8700 cameron road #100; 8700 cameron road #100; austin TX 78754
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 8700 cameron road #100; austin TX 78754
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7664949
• MDR Text Key: 113291186
• Report Number: 1651501-2018-00030
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K090076
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: literature
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 06/11/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/05/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: XXX-SALTO TALARIS IMPLANT
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2018
• 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: Unknown
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention
• Patient Age: 74 YR