FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H COATED STD STEM SIZE 3
MDR report key: 9805218
·
Received March 9, 2020
Report
- Report Number
- 3005180920-2020-00145
- Event Type
- Injury
- Date Received
- March 9, 2020
- Date of Event
- February 12, 2020
- Report Date
- March 9, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804090
- 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 19 FEBRUARY 2020: LOT 123307: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-OCT-2012. EXPIRATION DATE: 2017-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING OF PAIN DUE TO A POTTED STEM. THE CAUSE OF THE POTTED STEM IS UNKNOWN. THE SURGEON REVISED THE LINER AND STEM 7 YEARS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 271742 | STEM: AMISTEM H COATED STD STEM SIZE 3 | HIP UNCEMENTED STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.133 | 123307 | 07630030804090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |