MAUDE Adverse Event Report: ASCENSION ORTHOPEDICS SALTOS TALARIS IMPLANT; ANKLE REPLACEMENT

Device Problems Loose or Intermittent Connection (1371); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Unspecified Infection (1930)

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".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# 44 patient's age and gender - (b)(6) male ; bmi - 28.5; preoperative diagnosis - [right] ankle arthritis with varus deformity, s/p calcaneal osteotomy and lateral ligament reconstruction, mild subtalar arthritis; medical history - peripheral neuropathy, osteoarthritis, heart disease, myocardial infarction, htn, mitral valve prolapse, atrial fibrillation; operative history - right ankle calcaneal osteotomy and lateral ligament reconstruction; concomitant procedure - none; total follow-up (months) - 47; complication type - infection; complication onset (months) - 0; complication details - streptococcal cellulitis of pretibial area of right leg; complication treatment - iv antibiotics (vancomycin 1500 mg twice daily from day 8-12, 1750 mg twice daily from day 12); infection cleared as of day 48; complication rating - high.

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: SALTOS TALARIS IMPLANT
• Type of Device: ANKLE REPLACEMENT
• Manufacturer (Section D): ASCENSION ORTHOPEDICS; 11101 metric boulevard; austin TX 78758
• Manufacturer (Section G): ASCENSION ORTHOPEDICS; 11101 metric boulevard; austin TX 78758
• Manufacturer Contact: vivian nelson ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 7676197
• MDR Text Key: 113642425
• Report Number: 1651501-2018-00037
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/10/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/10/2018
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/26/2018
• Was Device Evaluated by Manufacturer?: No
• 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): Other
• Patient Age: 56 YR