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

Catalog Number XXX-SALTO TALARIS IMPLANT

Device Problems Device Operates Differently Than Expected (2913); Material Deformation (2976)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Information (3190)

Event Type  malfunction  

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

It was reported a general complaint by the surgeon who noticed limited bony ingrowth on the implant¿s coated surface, when doing revision cases of salto talaris ankle replacements over a course of a couple of years.He also noted that the coating¿s roughness changed when going to a new coating vendor (b)(4) approximately 5 years ago, and contributes this change to the cause of limited bony ingrowth.In his estimations that normal bony ingrowth covers about 50% of the coated surface, but only saw about 10% coverage with the new vendor.

Manufacturer Narrative

Integra has completed their internal investigation on september 28, 2017.Results: dhr review; a review of the lot record was not conducted, as the complaint was general in nature.No specific part number or lot number was identified.Complaints history; a review of the complaint records for the same product for the alleged hazardous situation/failure mode (bone failed to ¿ongrow¿) showed twelve complaints for this implant system having been received.Number of procedure = 1074 procedures as of (b)(6) 2017.Complaint rate = 12/1074*100 = 1.12%.Conclusion: as no implants were returned for investigation and due to the complaint¿s general nature, a possible root cause could not be found from the information provided.

• 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: sonia irizarry ; 311 enterprise drive; plainsboro, NJ 08536 ; 6099362393
• MDR Report Key: 6875091
• MDR Text Key: 87742007
• Report Number: 1651501-2017-00038
• 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: company representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2017

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?: Yes
• 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: 08/25/2017
• Initial Date FDA Received: 09/19/2017
• Supplement Dates Manufacturer Received: 09/28/2017
• Supplement Dates FDA Received: 09/29/2017
• 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