FDA Adverse Event
Injury
Summary report: N
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD
MDR report key: 3430204
·
Received October 17, 2013
Report
- Report Number
- 3005180920-2013-00122
- Event Type
- Injury
- Date Received
- October 17, 2013
- Date of Event
- September 18, 2013
- Report Date
- October 17, 2013
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: AMISTEM H CEMENTLESS FEMORAL STEM SIZE 3 STD: REF (B)(4) / LOT 110546 (60 STEMS PRODUCED): ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG. THE 59 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD 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 |
|---|---|---|---|---|---|---|---|
| 532068 | AMISTEM H FEMORAL CEMENTLESS STEM SIZE 3 STD | FEMORAL CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |