FDA Adverse Event
Injury
Summary report: N
TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES POROUS
MDR report key: 1092143
·
Received August 1, 2008
Report
- Report Number
- 2648920-2008-00041
- Event Type
- Injury
- Date Received
- August 1, 2008
- Date of Event
- February 12, 2008
- Report Date
- February 13, 2008
- Manufacturer
- ZIMMER MANUFACTURING B.V.
- Product Code
- KWB
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THIS REPORT WAS INITIALLY SUBMITTED UNDER THE MANUFACTURING FACILITY, ZIMMER INC. THE CORRECT MANUFACTURER FOR THIS COMPLAINT IS ZIMMER MANUFACTURING. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETED.
Description of Event or Problem · 1
IT IS REPORTED THAT THE DEVICE WAS IMPLANTED IN 2005. THE DEVICE WAS REVISED IN 2008, DUE TO LOOSENING. THE SURGEON NOTICED THAT THERE WAS A FILM ON THE SHELL THAT LOOKED SUSPICIOUS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY ACETABULAR SYSTEM SHELL WITH CLUSTER HOLES POROUS | HIP PROSTHESIS | KWB | ZIMMER MANUFACTURING B.V. | NA | 60286579 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |