FDA Adverse Event
Injury
Summary report: N
ZIMMER M/L TAPER FEMORAL STEM
MDR report key: 3093696
·
Received May 1, 2013
Report
- Report Number
- 1822565-2013-00729
- Event Type
- Injury
- Date Received
- May 1, 2013
- Report Date
- April 2, 2013
- Manufacturer
- ZIMMER INC
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, 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 AFTER A FALL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 189012 | ZIMMER M/L TAPER FEMORAL STEM | LZO | ZIMMER INC | 61000098 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other | (B)(4)| LOT #61188282| THE FOLLOWING ITEMS WERE MANUFACTURED BY ZIMMER| TRILOGY SHELL WITH CLUSTER HOLES:| ZIMMER KINECTIV MODULAR NECK: CATALOG #00784802200| CATALOG #00620005822, LOT #611112448| TRILOGY LONGEVITY POLY LINER: CATALOG #00631005836| VERSYS FEMORAL HEAD: CATALOG #00801803602| LOT #61192705| LOT #60810246 |