FDA Adverse Event
Injury
Summary report: N
TRILOGY LONGEVITY CONSTRAINED POLY LINER
MDR report key: 4212952
·
Received October 24, 2014
Report
- Report Number
- 1822565-2014-01448
- Event Type
- Injury
- Date Received
- October 24, 2014
- Date of Event
- July 27, 2014
- Report Date
- September 24, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWZ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
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 RECURRENT DISLOCATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 678890 | TRILOGY LONGEVITY CONSTRAINED POLY LINER | KWZ | ZIMMER, INC. | 62036279 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Required Intervention | LOT # 62082906, REMAINS IMPLANTED| LOT# 62381683 MFR BY ZIMMER (B)(4)| IMPLANTED| TM SHELL WITH MULTI HOLES, CATALOG# 00620205220,| VERSYS FEMORAL HEAD, CATALOG # 00801802814, |