FDA Adverse Event
Injury
Summary report: N
CONTINUUM SHELL WITH CLUSTER HOLES
MDR report key: 2994417
·
Received March 5, 2013
Report
- Report Number
- 1822565-2013-00434
- Event Type
- Injury
- Date Received
- March 5, 2013
- Report Date
- February 5, 2013
- Manufacturer
- ZIMMER, INC.
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, 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 PT IS EXPERIENCING PAIN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 93883 | CONTINUUM SHELL WITH CLUSTER HOLES | LZO | ZIMMER, INC. | 61629554 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | MFG BY ZIMMER (B)(4).| BIOLOX DELTA HEAD: CAT# 00877504002, LOT#2363776| LOT# 60113523| ZIMMER M/L FEMORAL STEM: CAT#00771101120, |