FDA Adverse Event
Injury
Summary report: N
GENESIS II
MDR report key: 1930104
·
Received December 16, 2010
Report
- Report Number
- 1020279-2010-00358
- Event Type
- Injury
- Date Received
- December 16, 2010
- Date of Event
- November 15, 2010
- Report Date
- March 31, 2011
- Manufacturer
- SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE DEVICE IS CURRENTLY UNDERGOING ANALYSIS.
Additional Manufacturer Narrative · 1
THE INSERTS WERE DIMENSIONALLY INSPECTED AND FOUND TO BE WITHIN SPECIFICATION. IT WAS FOUND THE SURGEON WAS NOT FAMILIAR WITH THE INSERTS EXPANDING WITH BODY TEMPERATURE AND TIGHTENING THE FIT.
Description of Event or Problem · 1
IT WAS REPORTED THAT THE INSERT WAS LOOSE WHEN PLACED INTO THE TIBIAL BASEPLATE. THE SURGOEN CEMENTED THE INSERT INTO PLACE. THIS EXTENDED SURGERY GREATER THAN 30 MINUTES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | GENESIS II | TIBIAL INSERT | JWH | SMITH & NEPHEW, INC., BROOKS MANUFACTURING SITE | 10DM03721 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Hospitalization| R | PRODUCT NUMBER: (B)(4), LOT NUMBER: 10DM04191A |