Model Number 7205000000 |
Device Problems
Fracture (1260); Fitting Problem (2183)
|
Patient Problems
Abrasion (1689); Infiltration into Tissue (1931)
|
Event Date 05/08/2021 |
Event Type
Injury
|
Event Description
|
It was reported by the user facility that the surgeon was reaming the acetabular wall when something in the drill reamer broke, which caused the reamer to start rotating oblong causing the reamer to damage the anterior wall.The surgeon stopped when he felt the reamer break in his hand and there was an additional hour to surgery to facilitate priming for alternate company shell/liner.
|
|
Manufacturer Narrative
|
Supplemental report submitted to document device evaluation results.Corrected data in d9.
|
|
Event Description
|
It was reported by the user facility that the surgeon was reaming the acetabular wall when something in the drill reamer broke, which caused the reamer to start rotating oblong causing the reamer to damage the anterior wall.The surgeon stopped when he felt the reamer break in his hand and there was an additional hour to surgery to facilitate priming for alternate company shell/liner.
|
|
Search Alerts/Recalls
|