FDA Adverse Event
Injury
Summary report: N
ZMR HIP SYSTEM FEMORAL STEM
MDR report key: 2210632
·
Received August 10, 2011
Report
- Report Number
- 1822565-2011-01839
- Event Type
- Injury
- Date Received
- August 10, 2011
- Date of Event
- July 14, 2011
- Report Date
- July 14, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- LWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WI, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
INFORMATION WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. A SUPPLEMENTAL REPORT WILL BE PROVIDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PATIENT WAS REVISED FOR A BROKEN STEM.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | ZMR HIP SYSTEM FEMORAL STEM | LWJ | ZIMMER, INC. | 75199700 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | LOT# 76287700| ZMR HIP SYSTEM FEMORAL BODY, CATALOG #00999208545 |