FDA Adverse Event
Injury
Summary report: N
UNKNOWN PRODUCT
MDR report key: 1759178
·
Received July 13, 2010
Report
- Report Number
- 2249697-2010-00837
- Event Type
- Injury
- Date Received
- July 13, 2010
- Date of Event
- May 14, 2010
- Report Date
- June 17, 2010
- Manufacturer
- STRYKER ORTHOPAEDICS MAHWAH
- Product Code
- JWH
- PMA / PMN Number
- UNK
- Removal / Correction Number
- NA
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NJ, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF AVAILABLE, IT WILL BE SUBMITTED IN THE SUPPLEMENTAL REPORT.
Description of Event or Problem · 1
SITE INDICATED: "(B) (6)2008: S/P ARTHROTOMY AND BX R KNEE."
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNKNOWN PRODUCT | IMPLANT | JWH | STRYKER ORTHOPAEDICS MAHWAH | NA | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 57 YR | Required Intervention |