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

Catalog Number XXX-SALTO TALARIS IMPLANT

Device Problem Device Operates Differently Than Expected (2913)

Patient Problem 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

One of 4 reports.Other mfg report numbers: 1651501-2017-00046, 1651501-2017-00047, 1651501-2017-00048, 1651501-2017-00049.A reported complaint literature of american orthopedic foot & ankle society (2017) published: "safety of outpatient total ankle arthroplasty vs.Traditional inpatient admission or overnight observation" which studies to evaluate ankle arthroplasty in an outpatient setting, and consistent with findings in other joint replacement procedures, it was a safe and effective alternative to hospital admission among similar patient cohorts.Base on the study, the results of this trial eighty-one patients underwent taa who met inclusion criteria, and 8 had a complication (10%).A significant difference in complication rate was seen among groups (p =.01) but not rate of readmission or reoperation.Of 16 patients, 5 (31%) who were admitted for 2 or more nights following surgery had a complication, as opposed to 3 of 65 (5%) who were outpatient or admitted overnight (p =.01).There were no differences in frequency of postoperative phone calls, narcotic refills, or visual analog scale pain scores at the first postoperative visit.There were no adverse medical events.The study concluded that with proper instruction, taa was performed safely in the outpatient setting.As health care policy continues to evolve in the united states, safe and efficient practices will remain a priority.

Manufacturer Narrative

Investigation completed on 1/30/2018.The complaint was initiated to document results from a literature review of an article.No device will be returned.Therefore, a failure analysis cannot be conducted.Since the complaint record does not provide any information relative to the device or the type of failure, a root cause cannot be determined at this time.

• 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: 7158334
• MDR Text Key: 96210002
• Report Number: 1651501-2017-00049
• Device Sequence Number: 1
• Product Code: HSN
• Combination Product (y/n): N
• PMA/PMN Number: K060544
• 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: 12/05/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• 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
• Initial Date Manufacturer Received: 12/05/2017
• Initial Date FDA Received: 01/02/2018
• Supplement Dates Manufacturer Received: 01/30/2018
• Supplement Dates FDA Received: 02/05/2018
• 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): Other