FDA Adverse Event
Injury
Summary report: N
APEX KNEE SYSTEM
MDR report key: 2963499
·
Received February 13, 2013
Report
- Report Number
- 1226188-2013-00011
- Event Type
- Injury
- Date Received
- February 13, 2013
- Date of Event
- January 16, 2013
- Report Date
- January 18, 2013
- Manufacturer
- OMNLIFE SCIENCE, INC.
- Product Code
- HSH
- PMA / PMN Number
- K080842
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UT, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
THE IMPLANTS WERE NOT RETURNED FOR EXAMINATION; THEREFORE, OMNI COULD NOT CONFIRM THE LOT NUMBERS OF THE PRODUCT REPORTED. BASED ON THE INFORMATION PROVIDED, A REVIEW OF MANUFACTURING LOT RECORDS WAS PERFORMED. ALL IMPLANT LOT RECORDS WERE REVIEWED AND THERE WERE NO DEVIATIONS REPORTED.
Description of Event or Problem · 1
SALES REPRESENTATIVE REPORTED THAT PATIENT WAS HAVING A REVISION SURGERY AS THE BONE SCAN SHOWED THE TIBIA WAS LOOSENING. INITIAL SURGERY WAS ON (B)(6) 2011 AND REVISION SURGERY WAS ON (B)(6) 2013. THE SALES REPRESENTATIVE REPORTED THAT THERE WAS NOTHING WRONG WITH THE TIBIAL TRAY IMPLANT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 63609 | APEX KNEE SYSTEM | PROSTHESIS, KNEE PATELLO/FEMOROTIBIAL | HSH | OMNLIFE SCIENCE, INC. | 8171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 36 YR | Hospitalization| R |