FDA Adverse Event
Injury
Summary report: N
AMISTEM H FEMORAL STEM
MDR report key: 3080651
·
Received April 15, 2013
Report
- Report Number
- 3005180920-2013-00038
- Event Type
- Injury
- Date Received
- April 15, 2013
- Date of Event
- March 6, 2013
- Report Date
- April 15, 2013
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 2 STD - REF. 01.18.132/ LOT 124046 (B)(4) STEMS PRODUCED). ALL PARAMETERS HAVE BEEN FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. (B)(4) STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO SIMILAR INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED.
Description of Event or Problem · 1
(B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 161100 | AMISTEM H FEMORAL STEM | FEMORAL STEM SIZE 2 STD CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 124046 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |