FDA Adverse Event
Injury
Summary report: N
ZIMMER M/L TAPER FEMORAL STEM
MDR report key: 3093694
·
Received May 1, 2013
Report
- Report Number
- 1822565-2013-00727
- Event Type
- Injury
- Date Received
- May 1, 2013
- Date of Event
- January 21, 2012
- Report Date
- April 1, 2013
- Manufacturer
- ZIMMER INC
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, 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 WAS EXPERIENCING PAIN. UPON EXAMINATION, IT WAS NOTED THAT THE STEM POSITION HAD CHANGED. THE PATIENT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189585 | ZIMMER M/L TAPER FEMORAL STEM | LZO | ZIMMER INC | 61925459 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 70 YR | Required Intervention |