FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 2
MDR report key: 8943843
·
Received August 29, 2019
Report
- Report Number
- 3005180920-2019-00726
- Event Type
- Injury
- Date Received
- August 29, 2019
- Date of Event
- August 4, 2019
- Report Date
- August 29, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804083
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- JA
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 08-AUGUST-2019: LOT 1901580: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06-MAY-2019. EXPIRATION DATE: 2024-04-23. NO ANOMALIES FOUND RELATED TO THE PROBLEM TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITH ANOTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ON (B)(4) 2019 WE WERE ALERTED OF A FRACTURE DISCOVERED 9 DAYS FROM THE PRIMARY SURGERY (THE CAUSE OF THE FRACTURE IS UNKNOWN BUT IT MAY HAVE OCCURRED DURING PRIMARY SURGERY) AND THE SURGEON REVISED (ON (B)(6) 2019) THE AMISTEM-H STEM WITH AMISTEM-C ONE AND THE PATIENT BONE WAS FIXED WITH THE CABLE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 738135 | STEM: AMISTEM H HA COATED STD STEM SIZE 2 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 1901580 | 07630030804083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |