FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 2
MDR report key: 8503591
·
Received April 11, 2019
Report
- Report Number
- 3005180920-2019-00260
- Event Type
- Injury
- Date Received
- April 11, 2019
- Date of Event
- July 20, 2018
- Report Date
- April 11, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804083
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 08 APRIL 2019: LOT 160641: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 11-MAY-2016. EXPIRATION DATE: 2021-04-21. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ON 12TH MARCH 2019 WE WERE ALERTED ABOUT A REVISION SURGERY HAPPENED ON (B)(6) 2018, AFTER 1 YEAR AND 11 MONTHS FROM THE PRIMARY, DUE TO PAIN CAUSED BY FEMORAL COMPONENT LOOSENING. THE PATIENT BEGAN TO HAVE PAIN THE (B)(6) 2017. DIAGNOSIS OF THE FEMORAL LOOSENING DONE IN (B)(6) 2017.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 298093 | STEM: AMISTEM H HA COATED STD STEM SIZE 2 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 160641 | 07630030804083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 63 YR | Required Intervention |