Model Number N/A |
Device Problem
Disconnection (1171)
|
Patient Problem
Unspecified Infection (1930)
|
Event Date 06/19/2015 |
Event Type
Injury
|
Event Description
|
It was reported that patient underwent a right total hip arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2015 due to infection.All components were removed and replaced with competitor spacer molds.During the procedure, the taper would not disengage between the proximal and distal arcos bodies.An osteotomy to remove the product was performed which caused a 45 minute delay in the procedure.
|
|
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: "early or late postoperative infection and/or allergic reaction." review of sterilization certification confirms device was sterilized in accordance with iso (b)(4).This report is number 3 of 9 mdrs filed for the same event (reference 1825034-2015-03040 / 03048).
|
|
Manufacturer Narrative
|
Product was returned to manufacturer, however evaluation is not necessary due to device being reported for infection.This report is number 3 of 9 mdrs filed for the same event (reference 1825034-2015-03040 / 03048).Reported for infection.
|
|
Manufacturer Narrative
|
The follow-up report is being filed to relay additional information that was unknown at the time of the initial medwatch.
|
|
Search Alerts/Recalls
|