FDA Adverse Event
Injury
Summary report: N
NEXGEN STEMMED TIBIAL COMPONENT
MDR report key: 3236424
·
Received July 11, 2013
Report
- Report Number
- 2648920-2013-00155
- Event Type
- Injury
- Date Received
- July 11, 2013
- Date of Event
- August 14, 2012
- Report Date
- June 12, 2013
- Manufacturer
- ZIMMER
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- PHYSICIAN
Narratives
Additional Manufacturer Narrative · 1
THIS BONE CEMENT IS MANUFACTURED AT HERAEUS MEDICAL AND DISTRIBUTED THROUGH ZIMMER ORTHOPAEDIC SURGICAL PRODUCTS. THIS REPORT WILL BE AMENDED WHEN OUR INVESTIGATION IS COMPLETE.
Description of Event or Problem · 1
IT IS REPORTED THAT THE PT WAS REVISED DUE TO LOOSENING.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 320393 | NEXGEN STEMMED TIBIAL COMPONENT | JWH | ZIMMER | 60057514 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention | PALACOS BONE CEMENT, CATALOG #UNK, LOT #UNK |