FDA Adverse Event
Malfunction
Summary report: N
APEX MODULAR HIP STEM
MDR report key: 2796370
·
Received October 12, 2012
Report
- Report Number
- 1226188-2012-00060
- Event Type
- Malfunction
- Date Received
- October 12, 2012
- Date of Event
- September 18, 2012
- Report Date
- October 11, 2012
- Manufacturer
- OMNILIFE SCIENCE, INC.
- Product Code
- LPH
- PMA / PMN Number
- K043123
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
NO ADDITIONAL INFORMATION.
Description of Event or Problem · 1
PRIOR TO IMPLANTING, IT WAS NOTICED THAT MODULAR NECK WOULD NOT COMPLETELY SEAT ON THE FEMORAL STEM. NO HARM TO PATIENT. APPROXIMATELY 10 MINUTE DELAY IN THE SURGICAL PROCEDURE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | APEX MODULAR HIP STEM | HIP PROSTHESIS, UNCEMENTED | LPH | OMNILIFE SCIENCE, INC. | 12001 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR |