FDA Adverse Event
Injury
Summary report: N
TRILOGY SHELL WITH HOLES
MDR report key: 3150103
·
Received May 30, 2013
Report
- Report Number
- 2648920-2013-00121
- Event Type
- Injury
- Date Received
- May 30, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 30, 2013
- Manufacturer
- ZIMMER
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NC, US
- 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 PATIENT WAS REVISED DUE TO THE CUP LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 237615 | TRILOGY SHELL WITH HOLES | LPH | ZIMMER | 61321067 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 66 YR | Required Intervention | 6.5MM TRILOGY SCREWS (X3): CATALOG #UNK, LOT #UNK |