FDA Adverse Event
Injury
Summary report: N
AMISTEM H HA COATED STD STEM SIZE 5
MDR report key: 7804985
·
Received August 22, 2018
Report
- Report Number
- 3005180920-2018-00624
- Event Type
- Injury
- Date Received
- August 22, 2018
- Date of Event
- July 24, 2018
- Report Date
- August 22, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804113
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 22 AUGUST 2018. LOT 140760: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 14 MAY 2014. EXPIRATION DATE: 2019-03-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN 1 YEAR AND 1 MONTH AFTER PRIMARY SURGERY. THE SURGEON DETERMINED THAT THE STEM WAS LOOSE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 647092 | AMISTEM H HA COATED STD STEM SIZE 5 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 140760 | 07630030804113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |