FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 0
MDR report key: 8573538
·
Received May 2, 2019
Report
- Report Number
- 3005180920-2019-00343
- Event Type
- Injury
- Date Received
- May 2, 2019
- Date of Event
- April 4, 2019
- Report Date
- May 2, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804069
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 30 APRIL 2019: LOT 153415: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 18-NOV-2015. EXPIRATION DATE: 2020-10-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY AFTER 11 MONTHS FROM THE PRIMARY DUE TO PAIN. THE SURGEON CONFIRMED THE STEM WAS LOOSE DISTALLY BUT WAS WELL FIXED PROXIMALLY AND HE WAS UNABLE TO REMOVE THE STEM. THE SURGEON CHOSE TO REVISE THE HEAD AND PLACE BIOCOMPOSITE BEADS AROUND THE STEM TO AIDE IN BONE GROWTH. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 367772 | STEM: AMISTEM H HA COATED STD STEM SIZE 0 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 153415 | 07630030804069 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |