WRIGHT MEDICAL TECHNOLOGY, INC. INBONE TOTAL ANKLE SYSTEM; PROSTHESIS, ANKLE, SEMI-CONSTRAINED, CEMENTED, METAL/POLYMER
|
Back to Search Results |
|
Model Number SEE H10 |
Device Problem
Material Separation (1562)
|
Patient Problem
No Code Available (3191)
|
Event Date 12/17/2018 |
Event Type
Injury
|
Manufacturer Narrative
|
The lot of the suspect device was not identified, therefore, the manufacturer cannot determine the suspect device.However, the suspect devices in use are part # 220220902, lot # 1466363; part # 220222206e, lot # 1475773; and part # 20034790x.The implants have been returned to the manufacturer for evaluation.Analysis results are not available at the time of this report.A follow-up report will be sent when the analysis is complete.
|
|
Event Description
|
Allegedly, the patient underwent a revision of total ankle.Upon explantation of the talar dome it was noticed that the plasma coating had chipped off under the surface.The patient was not adversely affected and the surgical case was not compromised in any way.Invision revision talar plate and talar dome were used as planned in the revision.Original ankle in patient for over a year.
|
|
Manufacturer Narrative
|
The talar dome, talar stem and poly insert were returned for evaluation.Overall, the poly insert did not show any gross deformation.The talar dome and talar stem were returned still seated together with some bone cement covering approximately half of the porous surface.Visual examination of all the devices showed a few heavier scratches/dings, which are consistent with removal during the revision surgery.Finally, examination of the talar dome found that some of the plasma spray is missing.
|
|
Search Alerts/Recalls
|
|
|