Model Number N/A |
Device Problems
Mechanical Problem (1384); Device Operates Differently Than Expected (2913); Noise, Audible (3273)
|
Patient Problem
Pain (1994)
|
Event Date 04/06/2015 |
Event Type
Injury
|
Event Description
|
It was reported that patient underwent a left partial knee arthroplasty on (b)(6) 2014.Subsequently, patient underwent a poly exchange on (b)(6) 2014 due to unknown reasons.Patient was further revised on (b)(4) 2015 due to pain and clicking.All components were removed and replaced with a total knee system.
|
|
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; ¿interoperative or postoperative bone fracture and/or postoperative pain¿ and / or "persistent pain." this report is number 1 of 2 mdrs filed for the same event (reference 1825034-2015-01841).
|
|
Manufacturer Narrative
|
This follow-up report is being filed to correct information and 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- 01840 / 01841).Discarded.
|
|
Search Alerts/Recalls
|