FDA Adverse Event
Injury
Summary report: N
TRILOGY LONGEVITY POLY LINER
MDR report key: 2871506
·
Received December 6, 2012
Report
- Report Number
- 2648920-2012-00259
- Event Type
- Injury
- Date Received
- December 6, 2012
- Date of Event
- September 7, 2010
- Report Date
- November 7, 2012
- Manufacturer
- ZIMMER
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED DUE TO INFECTION. THE PT ELECTED TO ONLY REMOVE THE HEAD AND LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY LONGEVITY POLY LINER | LPH | ZIMMER | 61320622 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention | LOT #61480241| VERSYS FEMORAL HEAD: CATALOG #00801804002, |