FDA Adverse Event
Other
Summary report: N
APEX TOTAL KNEE SYSTEM
MDR report key: 1909282
·
Received November 17, 2010
Report
- Report Number
- 1226188-2010-00017
- Event Type
- Other
- Date Received
- November 17, 2010
- Date of Event
- October 25, 2010
- Report Date
- October 25, 2010
- Manufacturer
- OMNI LIFE SCIENCE, INC
- Product Code
- JWH
- PMA / PMN Number
- K060192
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
IT WAS DISCOVERED AT THE END OF THE PROCEDURE THAT A RETAINING BOLT WAS NOT ORDERED WITH THE DOVETAIL TRAY CONNECTOR. SURGEON COMPLETED THE PROCEDURE USING BONE CEMENT AND A SUBSTITUTE BOLT.
Description of Event or Problem · 1
THE RETAINING BOLT FOR THE DOVETAIL TRAY CONNECTOR WAS NOT ORDERED PRIOR TO PROCEDURE. A TWENTY MINUTE DELAY IN SURGERY WAS EXPERIENCED. THE IMPLANT WAS FIXED BY SURGEON USING CEMENT AND A SUBSTITUTE BOLT. PATIENT CONDITION UNKNOWN AT THIS TIME. PRIMARY RIGHT TOTAL KNEE SURGERY: (B)(6) 2010.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX TOTAL KNEE SYSTEM | DOVETAIL TRAY CONNECTOR | JWH | OMNI LIFE SCIENCE, INC | 1347 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 77 YR | Required Intervention |