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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.
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Manufacturer (Section D)
11101 metric boulevard
austin TX 78758
Manufacturer (Section G)
11101 metric boulevard
austin TX 78758
Manufacturer Contact
vivian nelson
311 enterprise drive
plainsboro, NJ 08536
MDR Report Key7676197
MDR Text Key113642425
Report Number1651501-2018-00037
Device Sequence Number1
Product Code HSN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type literature
Reporter Occupation
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 Received07/10/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/26/2018
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 Unkown

Patient Treatment Data
Date Received: 07/10/2018 Patient Sequence Number: 1