FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 3
MDR report key: 9289245
·
Received November 7, 2019
Report
- Report Number
- 3005180920-2019-00935
- Event Type
- Injury
- Date Received
- November 7, 2019
- Date of Event
- October 8, 2019
- Report Date
- November 7, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804090
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 15 OCTOBER 2019: LOT 1901583: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14-MAY-2019. EXPIRATION DATE: 2024-05-05. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
PERIPROSTHETIC FRACTURE 2 OR 3 DAYS AFTER PRIMARY, FOLLOWING AN AMIS SURGERY PERFORMED ON (B)(6) 2019. THE FRACTURE HAS BEEN TREATED WITH 4 CERCLAGES, HEAD AND STEM WERE REVISED WITH COMPETITOR'S ITEMS. THE REVISION SURGERY DETAILS ARE UNKNOWN.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1087294 | STEM: AMISTEM H HA COATED STD STEM SIZE 3 | CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 1901583 | 07630030804090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 84 YR | Required Intervention |