FDA Adverse Event
Injury
Summary report: N
GENESIS I
MDR report key: 2181637
·
Received July 27, 2011
Report
- Report Number
- 1020279-2011-00280
- Event Type
- Injury
- Date Received
- July 27, 2011
- Date of Event
- June 21, 2011
- Report Date
- July 27, 2011
- Manufacturer
- SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CO, US
- Reporter Occupation
- RISK MANAGER
Narratives
Additional Manufacturer Narrative · 1
MEDWATCH REPORT # FILED BY THE RISK MANAGER FOR THIS COMPLAINT IS (B)(4).
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT SURGERY TIME WAS EXTENDED BEYOND 30 MINUTES DUE TO THE SURGEON HAVING ISSUES SEATING THE INSERT. IT WAS STATED THAT THE PRODUCT WOULD NOT BE RETURNED FOR EVALUATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS I | GNS ART ISRT MED RT 12MM | JWH | SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION | 05BM02285A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Hospitalization |