FDA Adverse Event
Malfunction
Summary report: N
TRABECULAR METAL ACETABULAR SHELL
MDR report key: 2193590
·
Received July 14, 2011
Report
- Report Number
- 1822565-2011-01658
- Event Type
- Malfunction
- Date Received
- July 14, 2011
- Date of Event
- June 13, 2011
- Report Date
- June 16, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JDI
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A FOREIGN SOURCE WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON COULD NOT SEAT THE LINER INTO THE SHELL. SURGERY WAS COMPLETED WITH A LARGER SIZE SHELL AND 10 DEGREE LINER INSTEAD OF 20 DEGREE LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TRABECULAR METAL ACETABULAR SHELL | JDI | ZIMMER, INC. | 61560711 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | TRILOGY ACETABULAR LONGEVITY LINER:| (B)(4)| CATALOG # 006320005028, |