Model Number N/A |
Device Problems
Material Too Rigid or Stiff (1544); Insufficient Information (3190)
|
Patient Problems
Limited Mobility Of The Implanted Joint (2671); No Code Available (3191)
|
Event Date 09/08/2015 |
Event Type
Injury
|
Manufacturer Narrative
|
Current information is insufficient to permit a conclusion as to the cause of the event.Review of device history records show that lot released with no recorded anomaly or deviation.There are warnings in the package insert that state that this type of event can occur: under possible adverse effects, number 12 states, ¿inadequate range of motion due to improper selection or positioning of components.¿.
|
|
Event Description
|
It was reported that patient underwent bilateral unicompartmental knee arthroplasty on (b)(6) 2015.A right knee revision procedure was performed on (b)(6) 2015 due to stiffness.During the procedure, the patient was converted to a vanguard ps total knee.
|
|
Manufacturer Narrative
|
This follow-up report is being filed to relay corrected information and additional information, which was unknown at the time of the initial medwatch.
|
|
Search Alerts/Recalls
|