FDA Adverse Event
Injury
Summary report: N
AMISTEM H COATED STD STEM SIZE 1
MDR report key: 10216607
·
Received July 1, 2020
Report
- Report Number
- 3005180920-2020-00366
- Event Type
- Injury
- Date Received
- July 1, 2020
- Date of Event
- June 11, 2020
- Report Date
- July 1, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804076
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 12 JUNE 2020: LOT 120916: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-JUN-2012. EXPIRATION DATE: 2017-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2016.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE STEM HEAD AND LINER 7 YEARS AND 5 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 681913 | AMISTEM H COATED STD STEM SIZE 1 | HIP UNCEMENTED STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.131 | 120916 | 07630030804076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |