FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 2
MDR report key: 10239481
·
Received July 7, 2020
Report
- Report Number
- 3005180920-2020-00392
- Event Type
- Injury
- Date Received
- July 7, 2020
- Date of Event
- June 9, 2020
- Report Date
- July 7, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804083
- 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 BY MEDACTA REGULATORY AFFAIRS DEPARTMENT ON 17 JUNE 2020: LOT 091940: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-SEP-2009. EXPIRATION DATE: 2014-07-30. 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
THE PATIENT CAME IN 9 YEARS AND 7 MONTHS FROM THE REVISION SURGERY REPORTING PAIN DUE TO A LOOSE STEM. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 705550 | STEM: AMISTEM H HA COATED STD STEM SIZE 2 | CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.132 | 091940 | 07630030804083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |