FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 4
MDR report key: 9374627
·
Received November 26, 2019
Report
- Report Number
- 3005180920-2019-00991
- Event Type
- Injury
- Date Received
- November 26, 2019
- Date of Event
- October 29, 2019
- Report Date
- November 26, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804106
- 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 07 NOVEMBER 2019: LOT 131159: 40 ITEMS MANUFACTURED AND RELEASED ON 03-JUN-2013. EXPIRATION DATE: 2018-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 40 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A POTTED STEM. ABOUT 6 YEARS AND 3 MONTHS AFTER PRIMARY THE SURGEON REVISED THE STEM AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1173221 | STEM: AMISTEM H HA COATED STD STEM SIZE 4 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 131159 | 07630030804106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |