FDA Adverse Event
Injury
Summary report: N
TRILOGY ACETABULAR SYSTEM LINER
MDR report key: 641146
·
Received October 13, 2005
Report
- Report Number
- 1822565-2005-00195
- Event Type
- Injury
- Date Received
- October 13, 2005
- Date of Event
- July 15, 2005
- Report Date
- September 12, 2005
- Manufacturer
- ZIMMER, INC.
- Product Code
- LPH
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICE WAS IMPLANTED ON APRIL 21, 1998, AND REVISED JULY 15, 2005, DUE TO BREAKAGE.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE DEVICE WAS IMPLANTED ON APRIL 1998 AND REVISED JULY 2005, DUE TO BREAKAGE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY ACETABULAR SYSTEM LINER | HIP PROSTHESIS | LPH | ZIMMER, INC. | NA | 40591400 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |