Model Number PHA01254 |
Device Problems
Break (1069); Difficult to Remove (1528)
|
Patient Problem
Insufficient Information (4580)
|
Event Type
Injury
|
Manufacturer Narrative
|
This event will be updated once the investigation is complete.Trends will be evaluated.
|
|
Event Description
|
Allegedly, ti modular neck broke when pt picked up a potted plant.Attempted to remove with mpo remnant removal tray, 2 drill bits and a tap broke in the process.Surgeon also attempted to bur out neck with metal bur, this also did not work.Surgeon also attempted to remove with osteotomes, this did not work.After 4 hours the surgeon was finally able to remove the stem by performing an eto.Implants not revised: partid: conserve® plus cup 56mm id 62mm od beaded,item#38025662, lot#087457365, qty:1.
|
|
Manufacturer Narrative
|
This event will be updated once the investigation is complete.Trends will be evaluated.
|
|
Event Description
|
Allegedly, ti modular neck broke when pt picked up a potted plant.Attempted to remove with mpo remnant removal tray, 2 drill bits and a tap broke in the process.Surgeon also attempted to bur out neck with metal bur, this also did not work.Surgeon also attempted to remove with osteotomes, this did not work.After 4 hours the surgeon was finally able to remove the stem by performing an eto.Implants not revised: partid: conserve® plus cup 56mm id 62mm od beaded,item#38025662, lot#087457365, qty:1.
|
|
Manufacturer Narrative
|
A minor change in section h.3, in the initial report the selection "no" was checked and changed to no returned to manufacturer.
|
|
Search Alerts/Recalls
|
|