FDA Adverse Event
Injury
Summary report: N
AMISTEM H FEMORAL STEM
MDR report key: 3430196
·
Received October 17, 2013
Report
- Report Number
- 3005180920-2013-00124
- Event Type
- Injury
- Date Received
- October 17, 2013
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- KWY
- PMA / PMN Number
- K093944
- Report Source
- Manufacturer report
- Reporter Location
- UK
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 2 STD - REF (B)(4) / LOT 131153 (60 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. THE 43 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY SOLD AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, WE DO NOT HAVE EVIDENCES THAT THE EVENT IS DEVICE RELATED.
Description of Event or Problem · 1
REF MFR 3006639916-2013-00124.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 532334 | AMISTEM H FEMORAL STEM | FEMORAL STEM SIZE 2 STD CEMENTLESS | KWY | MEDACTA INTERNATIONAL, SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |