FDA Adverse Event
Injury
Summary report: N
NEXGEN LOCK ARTICULAR SURFACE
MDR report key: 3954909
·
Received July 16, 2014
Report
- Report Number
- 1822565-2014-00864
- Event Type
- Injury
- Date Received
- July 16, 2014
- Date of Event
- June 19, 2014
- Report Date
- June 19, 2014
- Manufacturer
- ZIMMER, INC.
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
- 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 PRESENTED WITH PAIN. X-RAY CONFIRMED THAT LOCKING BOLT FROM THE ARTICULAR SURFACE HAD LOOSENED. AS A RESULT, THE PT WAS REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 416311 | NEXGEN LOCK ARTICULAR SURFACE | JWH | ZIMMER, INC. | 78049000 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |