FDA Adverse Event
Other
Summary report: N
UNIVERSAL 2 TOTAL WRIST IMPLANT
MDR report key: 1314438
·
Received February 17, 2009
Report
- Report Number
- 3004608878-2009-00011
- Event Type
- Other
- Date Received
- February 17, 2009
- Date of Event
- February 1, 2009
- Report Date
- February 17, 2009
- Manufacturer
- INTEGRA LIFESCIENCES CORPORATION
- Product Code
- JWJ
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- GM
Narratives
Additional Manufacturer Narrative · 1
TO DATE, THE DEVICE INVOLVED IN THE REPORTED INCIDENT HAS NOT BEEN RECEIVED FOR EVALUATION. AN INVESTIGATION HAS BEEN INITIATED BASED UPON THE REPORTED INFORMATION.
Description of Event or Problem · 1
THE REPORTER STATED IN EMAIL THAT SINCE THE TIME OF THE IMPLANT, THE PATIENT HAS EXPERIENCED PROBLEMS INCLUDING RESTRICTED MOVEMENT, PAIN, CIRCULATION TROUBLE, IMPAIRED FEELING AND MUSCLE FUNCTION, LOSS OF STRENGTH AND PROGRESSIVE WEAKNESS IN THE HAND. CARTILAGE DAMAGE IS SUSPECTED. REVISION SURGERY IS PLANNED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNIVERSAL 2 TOTAL WRIST IMPLANT | TOTAL WRIST IMPLANT SYSTEM | JWJ | INTEGRA LIFESCIENCES CORPORATION | UNK | NOT KNOWN |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 25 YR |