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.
|
|
Search Alerts/Recalls
|