FDA Adverse Event
Injury
Summary report: N
TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES POROUS
MDR report key: 703298
·
Received April 22, 2006
Report
- Report Number
- 2648920-2006-00008
- Event Type
- Injury
- Date Received
- April 22, 2006
- Date of Event
- March 13, 2006
- Report Date
- March 20, 2006
- Manufacturer
- ZIMMER MFG. B.V.
- Product Code
- JDI
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2006. REVISION TOOK PLACE ON MARCH 13, 2006 DUE TO PROTUSION INTO THE PELVIC CAVITY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES POROUS | HIP PROSTHESIS | JDI | ZIMMER MFG. B.V. | NA | 60295097 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 80 YR | Hospitalization| R |