FDA Adverse Event
Injury
Summary report: N
OMNI HIP SYSTEM
MDR report key: 6202229
·
Received December 23, 2016
Report
- Report Number
- 1226188-2016-00111
- Event Type
- Injury
- Date Received
- December 23, 2016
- Date of Event
- December 7, 2016
- Report Date
- December 8, 2016
- Manufacturer
- OMNILIFE SCIENCE, INC.
- Product Code
- LPH
- PMA / PMN Number
- K090845
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE COMPLAINANT MADE NO INDICATION OF ANY OMNILIFE SCIENCE DEVICE MALFUNCTION OR DEFICIENCY RELATED TO THE IDENTITY, QUALITY, DURABILITY, RELIABILITY, SAFETY, EFFECTIVENESS OR DEVICE PERFORMANCE CONTRIBUTING TO THE ADVERSE EVENT. 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) 2011. THE REVISION SURGERY OCCURRED DUE TO METALLOSIS. DURING THIS REVISION, ARC STEM AND NECK WERE REPLACED WITH NON-OMNI PRODUCTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 852304 | OMNI HIP SYSTEM | PROSTHESIS, HIP, SEMI-CONSTRAINED | LPH | OMNILIFE SCIENCE, INC. | 8230 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 74 YR | Hospitalization| R |