FDA Adverse Event
Injury
Summary report: N
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD
MDR report key: 4345605
·
Received December 11, 2014
Report
- Report Number
- 3005180920-2014-00183
- Event Type
- Injury
- Date Received
- December 11, 2014
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 5 STD: REF 01.18.135 / LOT 130602 ((B)(4) STEMS PRODUCED / (B)(4) SOLD WITHOUT ANY SIMILAR ISSUE): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDING WASHING AND STERILIZATION PROCEDURES. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.
Description of Event or Problem · 1
IMP REF # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 804089 | AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD | FEMORAL CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |