FDA Adverse Event
Injury
Summary report: N
TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER
MDR report key: 646375
·
Received November 15, 2005
Report
- Report Number
- 1822565-2005-00216
- Event Type
- Injury
- Date Received
- November 15, 2005
- Date of Event
- June 2, 2005
- Report Date
- October 12, 2005
- Manufacturer
- ZIMMER, INC.
- Product Code
- KWZ
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICE WAS IMPLANTED 05/23/2005. THE DEVICE WAS REVISED POST-OP LATER ON DUE TO THE HEAD PULLING OUT OF THE LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY ACETABULAR SYSTEM CONSTRAINED LINER | HIP PROSTHESIS | KWZ | ZIMMER, INC. | NA | 60238208 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNKNOWN | Hospitalization| R |