FDA Adverse Event
Injury
Summary report: N
TRILOGY ALUMINA INSERT
MDR report key: 4101608
·
Received August 27, 2014
Report
- Report Number
- 1822565-2014-01038
- Event Type
- Injury
- Date Received
- August 27, 2014
- Date of Event
- July 10, 2014
- Report Date
- August 1, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- MRA
- Adverse Event
- Yes
- 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 THE PATIENT WAS REVISED TO ADDRESS PAIN AND AN AUDIBLE NOISE. DURING THE REVISION, IT WAS NOTICED THE LINER WAS BROKEN; THEREFORE, THE LINER WAS REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 522563 | TRILOGY ALUMINA INSERT | MRA | ZIMMER, INC. | 60016158 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |