FDA Adverse Event
Injury
Summary report: N
TM COLLARLESS FEMORAL STEM
MDR report key: 2875123
·
Received December 12, 2012
Report
- Report Number
- 1822565-2012-02515
- Event Type
- Injury
- Date Received
- December 12, 2012
- Report Date
- November 13, 2012
- Manufacturer
- ZIMMER, INC.
- Product Code
- LPH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- 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 PATIENT IS EXPERIENCING PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TM COLLARLESS FEMORAL STEM | LPH | ZIMMER, INC. | 61749920 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | CATALOG #00875101240, LOT #61959392| MANUFACTURED BY ZIMMER (B)(4)| CONTINUUM, TRILOGY IT, ALLOFIT IT POLY LINER| CATALOG #00875705601, LOT #62021353| CONTINUUM TM SHELL WITH CLUSTER HOLES |