FDA Adverse Event
Summary report: N
GMK PS FEMUR CEMENTED SIZE 2 LEFT
MDR report key: 3140304
·
Received May 24, 2013
Report
- Report Number
- 3006639916-2013-00054
- Date Received
- May 24, 2013
- Date of Event
- April 22, 2013
- Report Date
- May 24, 2013
- Manufacturer
- MEDACTA INTL SA
- Product Code
- JWH
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- AU
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
FRACTURE OF THE MEDIAL FEMUR CONDYLE DETECTED 1 WEEK POST SURGERY. REF MFR REPORT# 3005180920-2013-00054.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 231140 | GMK PS FEMUR CEMENTED SIZE 2 LEFT | KNEE FEMUR COMPONENT | JWH | MEDACTA INTL SA | 124192 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |