FDA Adverse Event
Injury
Summary report: N
QUADRA H FEMORAL STEM SIZE 3 LATERALIZED
MDR report key: 4143547
·
Received September 5, 2014
Report
- Report Number
- 3006639916-2014-00115
- Event Type
- Injury
- Date Received
- September 5, 2014
- Date of Event
- August 6, 2014
- Report Date
- September 5, 2014
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KWY
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
REVISION SURGERY DUE TO A PERIPROSTHETIC FEMORAL FRACTURE. MFR REF# 3005180920-2014-00115.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 544466 | QUADRA H FEMORAL STEM SIZE 3 LATERALIZED | FEMORAL CEMENTLESS STEM LAT | KWY | MEDACTA INTERNATIONAL SA | 072255 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |