FDA Adverse Event
Malfunction
Summary report: N
APEX KNEE SYSTEM
MDR report key: 2154888
·
Received June 24, 2011
Report
- Report Number
- 1226188-2011-00007
- Event Type
- Malfunction
- Date Received
- June 24, 2011
- Date of Event
- May 12, 2011
- Report Date
- May 27, 2011
- Manufacturer
- OMNILIFE SCIENCE, INC.
- Product Code
- JWH
- PMA / PMN Number
- K060192
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SP
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
PATELLA DRILL SHOWED SIGNS OF DAMAGE, THIS MAY HAVE BEEN CAUSED IF THE SURGEON DID NOT DRILL AXIAL TO THE HOLE ON DRILL GUIDE. THE MOST LIKELY CAUSE OF THE EVENT IS DUE TO USE ERROR. ADDITIONAL MODEL NUMBER: WS-10150.
Description of Event or Problem · 1
PATELLA DRILL GOT STUCK ON THE PATELLA DRILL GUIDE, 15 MINUTE DELAY IN SURGERY. PATIENT WAS NOT EFFECTED BY THE DELAY. PATIENT IS DOING WELL POST SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX KNEE SYSTEM | PATELLA DRILL | JWH | OMNILIFE SCIENCE, INC. | WS-40001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR |