FDA Adverse Event
Injury
Summary report: N
QUADRA H FEMORAL STEM SIZE 2 STD
MDR report key: 4218008
·
Received July 30, 2014
Report
- Report Number
- 3005180920-2014-00106
- Event Type
- Injury
- Date Received
- July 30, 2014
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- PMA / PMN Number
- K082792
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: QUADRA H CEMENTLESS FEMORAL STEM SIZE 2 STD REF. 01.12.022 / LOT 090111 ((B)(4) STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. ALL THE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED AND FROM THE INFORMATION RECEIVED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.
Description of Event or Problem · 1
REF IMPORTER REPORT (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 446024 | QUADRA H FEMORAL STEM SIZE 2 STD | FEMORAL CEMENTLESS STEM STD | JDI | MEDACTA INTERNATIONAL SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |