FDA Adverse Event
Injury
Summary report: N
GENESIS II
MDR report key: 2033049
·
Received March 30, 2011
Report
- Report Number
- 1020279-2011-00104
- Event Type
- Injury
- Date Received
- March 30, 2011
- Date of Event
- December 9, 2010
- Report Date
- April 13, 2011
- Manufacturer
- SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NY, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
AFTER AN EXTENSIVE INVESTIGATION BY QUALITY, IT HAS BEEN DETERMINED THAT THIS IS AN ISOLATED SUPPLIER INCIDENT. IT WAS FOUND THAT THE POSTERIOR UNDERCUT WAS NOT FINISHED TO THE REQUIRED PROFILE/POSITION BECAUSE THE MACHINE TOOL BROKE. THE PRODUCT WAS NOT PROPERLY IDENTIFIED AS DISCREPANT BY THE SUPPLIER, SUBSEQUENTLY ALLOWING THE PRODUCT TO PROCEED THROUGH THE PROCESS. THE SUPPLIER HAS BEEN NOTIFIED AND ISSUED A CORRECTIVE ACTION REQUEST TO IDENTIFY AND ADDRESS GAPS IN THEIR PROCESSES.
Description of Event or Problem · 1
IT HAS BEEN REPORTED THAT SURGERY TIME WAS EXTENDED BEYOND 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS II | TIBIA | JWH | SMITH & NEPHEW, INC. ORTHOPAEDIC DIVISION | 10GAF0010 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 68 YR | Hospitalization| R | PART # 71420818, LOT # 10KM05754| PART # 71421509, LOT # 10JM01694 |