Model Number N/A |
Device Problem
Device Dislodged or Dislocated (2923)
|
Patient Problems
Joint Dislocation (2374); No Code Available (3191)
|
Event Date 09/29/2015 |
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 10 states, ¿loosening or migration of the implants can occur due to loss of fixation, trauma, malalignment, bone resorption, excessive activity.¿ number 13 states, "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity can also contribute to these conditions.".
|
|
Event Description
|
It was reported that patient underwent an initial right partial knee arthroplasty on (b)(6) 2015.Subsequently, the patient underwent a revision procedure on (b)(6) 2015 due to dislocation.The bearing was removed and replaced.
|
|
Manufacturer Narrative
|
This follow-up report is being filed to relay additional information, which was unknown at the time of the initial medwatch.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04381-1 / 2016-00050).
|
|
Event Description
|
It was reported that patient underwent an initial right partial knee arthroplasty on (b)(6), 2015.Subsequently, the patient underwent a revision procedure on (b)(6), 2015 due to dislocation.The bearing was removed and replaced.Additional information received reported patient underwent a revision procedure on (b)(6) 2015 due to dislocation.During the procedure, patient was revised to a total knee system.
|
|
Manufacturer Narrative
|
This follow-up report is being filed to correct information.This report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-04381-1 / 2016-00050).Requested but not returned by hospital.
|
|
Search Alerts/Recalls
|