FDA Adverse Event
Malfunction
Summary report: N
AMISTEM H HA COATED LAT STEM SIZE 5
MDR report key: 7525807
·
Received May 18, 2018
Report
- Report Number
- 3005180920-2018-00341
- Event Type
- Malfunction
- Date Received
- May 18, 2018
- Date of Event
- April 18, 2018
- Report Date
- May 18, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804212
- PMA / PMN Number
- K093944
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 17-MAY-2018. LOT 162262: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-JULY-2016. EXPIRATION DATE: 2021-06-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
STEM WAS FOUND TO BE LOOSE INSIDE PACKAGING. THIS CAUSED COATING DETACHMENT. A STEM BACK-UP WAS USED, THE PACKAGING WAS SCRATCHED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 370583 | AMISTEM H HA COATED LAT STEM SIZE 5 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 162262 | 07630030804212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 65 YR | Other |