FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM COLLARED STEM HA COATED STD SIZE 2
MDR report key: 9222732
·
Received October 23, 2019
Report
- Report Number
- 3005180920-2019-00888
- Event Type
- Injury
- Date Received
- October 23, 2019
- Date of Event
- September 23, 2019
- Report Date
- October 23, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804571
- PMA / PMN Number
- K121011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2019: LOT 161473: 15 ITEMS MANUFACTURED AND RELEASED ON 22-JUN-2016. EXPIRATION DATE: 2021-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 15 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN, ABOUT THREE YEARS AFTER PRIMARY SURGERY, COMPLAINING OF PAIN DUE TO A LOOSE FEMORAL STEM. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1016853 | STEM: AMISTEM COLLARED STEM HA COATED STD SIZE 2 | UNCEMENTED HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 161473 | 07630030804571 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |