FDA Adverse Event
Injury
Summary report: N
KNEE IMPLANT
MDR report key: 2142483
·
Received June 28, 2011
Report
- Report Number
- 1020279-2011-00226
- Event Type
- Injury
- Date Received
- June 28, 2011
- Date of Event
- December 20, 2010
- Report Date
- June 28, 2011
- Manufacturer
- SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
VOLUNTARY REPORT FILED WITH THE FDA UNDER REPORT # (B)(4) BY THE PATIENT. SMITH & NEPHEW, INC. WAS MADE AWARE VIA THE FDA.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT THE PATIENT WAS SEDATED TO MANUALLY MANIPULATE A DISLOCATED KNEE BACK IN TO PLACE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | KNEE IMPLANT | INSERT | JWH | SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R |