FDA Adverse Event
Malfunction
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 1051193
·
Received May 22, 2008
Report
- Report Number
- 1226188-2008-00012
- Event Type
- Malfunction
- Date Received
- May 22, 2008
- Date of Event
- April 21, 2008
- Report Date
- May 21, 2008
- Manufacturer
- OMNI LIFE SCIENCE INC.
- Product Code
- KWY
- PMA / PMN Number
- K000788
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL DEVICE: NECK, MEDIUM 47.5 NEUTRAL LOT 1337; EXPIRATION 04/30/2011.
Description of Event or Problem · 1
DURING THA, SURGEON COULD NOT GET MODULAR NECK AND STEM TO SEAT TOGETHER WITHOUT A GAP. AFTER A DELAY OF 40 MINUTES, ANOTHER NECK AND STEM WAS IMPLANTED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | POROUS FEMORAL STEM | KWY | OMNI LIFE SCIENCE INC. | 151456 | 1616 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention |