FDA Adverse Event
Malfunction
Summary report: N
TRILOGY ACETABULAR SHELL WITHOUT HOLES
MDR report key: 2222862
·
Received August 10, 2011
Report
- Report Number
- 2648920-2011-00042
- Event Type
- Malfunction
- Date Received
- August 10, 2011
- Date of Event
- April 12, 2011
- Report Date
- July 13, 2011
- Manufacturer
- ZIMMER,
- Product Code
- LPH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA
- Reporter Occupation
- PHYSICIAN
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 SCRUB NURSE OPENED THE IMPLANT AND FOUND THAT THE IMPLANT HAD A DEFECT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRILOGY ACETABULAR SHELL WITHOUT HOLES | LPH | ZIMMER, | 61452212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |