FDA Adverse Event
Injury
Summary report: N
TC-PLUS
MDR report key: 2182381
·
Received July 28, 2011
Report
- Report Number
- 9613369-2011-00034
- Event Type
- Injury
- Date Received
- July 28, 2011
- Date of Event
- July 15, 2011
- Report Date
- July 27, 2011
- Manufacturer
- SMITH & NEPHEW, INC. AG
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN RECEIVED FOR DEVICES ASSOCIATED WITH THIS EVENT. THE DEVICES ARE NOT MARKETED OR SOLD IN THE US.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO EARLY INFECTION. LITTLE INFORMATION IS KNOWN AS THIS CASE WAS PART OF AN OBSERVATIONAL STUDY IN (B)(6).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | TC-PLUS | TC PRIM FEMORAL COMP LEFT 8S NON-CEM | JWH | SMITH & NEPHEW, INC. AG | A1024961 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 46 YR | Hospitalization| R | (B)(4)| (B)(4) |