FDA Adverse Event
Injury
Summary report: N
OMNI HIP SYSTEM
MDR report key: 6202221
·
Received December 23, 2016
Report
- Report Number
- 1226188-2016-00114
- Event Type
- Injury
- Date Received
- December 23, 2016
- Date of Event
- September 26, 2016
- Report Date
- December 5, 2016
- Manufacturer
- OMNILIFE SCIENCE, INC.
- Product Code
- LPH
- PMA / PMN Number
- K000788
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
REVIEW OF THE MANUFACTURING DOCUMENTATION AND STERILIZATION DOCUMENTATION FOR THE DEVICES IN QUESTION REVEALED NO DEVIATION FROM PROCESS OR NON-CONFORMITY OF PRODUCT THAT WOULD HAVE CAUSED OR CONTRIBUTED TO THE ADVERSE EVENT.
Description of Event or Problem · 1
THE COMPLAINT INVOLVED A PATIENT WHO UNDERWENT A HIP REVISION SURGERY ON (B)(6) 2016. THE ORIGINAL SURGERY IS DATED (B)(6) 2003. THE REVISION SURGERY OCCURRED BECAUSE OF PATIENT PAIN FOLLOWING A POPPING SENSATION. DURING THE REVISION, THE FEMORAL STEM, THE MODULAR NECK AND FEMORAL HEAD WERE REVISED TO NEW NON-OMNI COMPONENTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 852366 | OMNI HIP SYSTEM | PROSTHESIS, HIP, SEMI-CONTRAINED | LPH | OMNILIFE SCIENCE, INC. | 160 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Hospitalization| R |