FDA Adverse Event
Injury
Summary report: N
AMISTEM P STD STEM SIZE 2
MDR report key: 10669526
·
Received October 13, 2020
Report
- Report Number
- 3005180920-2020-00710
- Event Type
- Injury
- Date Received
- October 13, 2020
- Date of Event
- September 18, 2020
- Report Date
- October 13, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720014
- PMA / PMN Number
- K173794
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON OCTOBER 13TH 2020: LOT 180726: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JUNE 2018. EXPIRATION DATE: 2023-06-12. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY PERFORMED DUE TO STEM LOOSENING, PROXIMALLY, 1 YEAR AND 9 MONTHS AFTER THE PRIMARY SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1135996 | AMISTEM P STD STEM SIZE 2 | HIP UNCEMENTED STEM | LZO | MEDACTA INTERNATIONAL SA | 180726 | 07630040720014 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Required Intervention |