FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM-P COLLARED STD. SIZE 2
MDR report key: 11115833
·
Received January 5, 2021
Report
- Report Number
- 3005180920-2021-00009
- Event Type
- Injury
- Date Received
- January 5, 2021
- Date of Event
- November 19, 2020
- Report Date
- January 5, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720212
- PMA / PMN Number
- K173794
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 18 DECEMBER 2020: LOT 1910426: 115 ITEMS MANUFACTURED AND RELEASED ON 17-JUN-2020. EXPIRATION DATE: 2025-08-03. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 77 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
TWO MONTHS AFTER PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE FEMORAL STEM. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR PRODUCTS, AND REVISED THE LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 11696 | STEM: AMISTEM-P COLLARED STD. SIZE 2 | FEMORAL STEM: AMISTEM-P COLLARED | LZO | MEDACTA INTERNATIONAL SA | 1910426 | 07630040720212 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |