FDA Adverse Event
Injury
Summary report: N
UNKNOWN_RECONSTRUCTIVE_PRODUCT
MDR report key: 3159900
·
Received June 10, 2013
Report
- Report Number
- 0002249697-2013-01876
- Event Type
- Injury
- Date Received
- June 10, 2013
- Date of Event
- October 17, 1994
- Report Date
- May 14, 2013
- Manufacturer
- STRYKER ORTHOPAEDICS-MAHWAH
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ADDITIONAL INFORMATION PROVIDED CONFIRMED THE DEVICE REPORTED IS MANUFACTURED BY SYNTHES AND IS NOT STRYKER DEVICE.
Additional Manufacturer Narrative · 1
CATALOGUE NUMBER UNKNOWN AT THIS TIME. DEVICE DESCRIPTION REPORTED AS UNKNOWN RIGHT STRYKER KNEE. ADDITIONAL INFORMATION HAS BEEN REQUESTED AND IF RECEIVED WILL BE SUBMITTED IN A FOLLOW UP REPORT UPON COMPLETION OF THE INVESTIGATION. DEVICE REMAINS IMPLANTED.
Description of Event or Problem · 1
IT WAS REPORTED THAT: THE PATIENT HAS SWELLING, REDNESS, AND LEGS ARE VERY WEAK. PATIENT WANTS TO KNOW IF KNEE HAS BEEN RECALLED.
Description of Event or Problem · 1
IT WAS REPORTED THAT: THE PATIENT HAS SWELLING, REDNESS, AND LEGS ARE VERY WEAK. PATIENT WANTS TO KNOW IF KNEE HAS BEEN RECALLED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 259593 | UNKNOWN_RECONSTRUCTIVE_PRODUCT | IMPLANT | JWH | STRYKER ORTHOPAEDICS-MAHWAH | UNKNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 15 YR | Other |