Model Number N/A |
Device Problems
Material Separation (1562); Unstable (1667); Device Dislodged or Dislocated (2923)
|
Patient Problem
No Code Available (3191)
|
Event Date 12/30/2014 |
Event Type
Injury
|
Event Description
|
It was reported patient underwent an initial total hip arthroplasty on (b)(6) 2014.Subsequently, patient was revised on (b)(6) 2014 due to dislocation and instability.When the patient was opened, the poly and head had separated.The modular head and bearing were removed and replaced.A longer neck was utilized in the revision.
|
|
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, it states: "dislocation and subluxation due to inadequate fixation and improper positioning.Muscle and fibrous tissue laxity may also contribute to these conditions." device availability - the device is reported to be available for evaluation; however, it has not been received by biomet orthopedics to date.In the event that the device is received and evaluated, a follow up report will be sent to the fda to provide results.This report is number 2 of 2 mdrs filed for the same event (reference 1825034-2015-00300/ -00301).
|
|
Manufacturer Narrative
|
This follow-up report is being filed to relay additional information which was unknown at the time of the initial medwatch and to report device evaluation results.There is no indication with the information available that there was any non-conformance with the component as manufactured.The likely cause is something external to the function of the implant whereby the conditions of use caused or contributed to this event.
|
|
Search Alerts/Recalls
|