FDA Adverse Event
Injury
Summary report: N
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD
MDR report key: 3322028
·
Received August 23, 2013
Report
- Report Number
- 3005180920-2013-00100
- Event Type
- Injury
- Date Received
- August 23, 2013
- 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. (B)(4) / LOT 130602 (100 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING. THIRTY NINE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED WITHOUT ANY OTHER SIMILAR INCIDENT. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.
Description of Event or Problem · 1
REF IMP # (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 413426 | AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD | FEMORAL CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |