FDA Adverse Event
Injury
Summary report: N
AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD
MDR report key: 4297159
·
Received November 14, 2014
Report
- Report Number
- 3005180920-2014-00155
- Event Type
- Injury
- Date Received
- November 14, 2014
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- KWY
- 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# 132148 ((B)(4) STEMS PRODUCED/ (B)(4)SOLD): NO ANOMALIES FOUND. AMISTEM H BROCH SIZE 8: REF. 01.18.10.105/ LOT# 1212263 ((B)(4) REUSABLE BROACHES PRODUCED): NO ANOMALIES FOUND. STEM EXTRACTOR: CODE 01.15.10.0038 - LOT# 1110203 ((B)(4) REUSABLE EXTRACTORS PRODUCED): NO ANOMALIES FOUND. FROM THE DATA COLLECTED, THERE ARE NO EVIDENCES THAT THE EVENT IS DEVICE RELATED. SIMILAR CASE TO MDR # 2014-00154, WITH THE SAME SURGEON.
Description of Event or Problem · 1
PLEASE REFER IMPORTER REPORT#: (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 739000 | AMISTEM H FEMORAL CEMENTLESS STEM SIZE 5 STD | FEMORAL CEMENTLESS STEM | KWY | MEDACTA INTERNATIONAL SA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |