FDA Adverse Event
Injury
Summary report: N
MODULAR CEMENTED TIBIAL BASEPLATE
MDR report key: 2212623
·
Received August 11, 2011
Report
- Report Number
- 1822565-2011-01857
- Event Type
- Injury
- Date Received
- August 11, 2011
- Date of Event
- June 28, 2011
- Report Date
- July 12, 2011
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MN, US
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
INFO WAS RECEIVED FROM A DISTRIBUTOR WHO IS NOT REQUIRED TO COMPLETE FORM 3500A. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE SURGEON COULD NOT SEAT THE STEMMED TIBIA IN THE BONE, SO HE DECIDED TO USE THE NON-STEMMED TIBIAL COMPONENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | MODULAR CEMENTED TIBIAL BASEPLATE | JWH | ZIMMER, INC. | 61136008 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | LOT #61784252| NATURAL KNEE REVISION STEM: CATALOG #621575145, |