FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD SIZE 4
MDR report key: 11626185
·
Received April 7, 2021
Report
- Report Number
- 3005180920-2021-00267
- Event Type
- Injury
- Date Received
- April 7, 2021
- Date of Event
- March 8, 2021
- Report Date
- April 7, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804106
- 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 06 APRIL 2021: LOT 133211: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-OCT-2013. EXPIRATION DATE: 2018-09-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT SINCE 2017.
Description of Event or Problem · 1
THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE OF THE LOOSE STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD WITH COMPETITOR IMPLANTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER ALMOST 6 YEARS AND 11 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 528035 | STEM: AMISTEM H HA COATED STD SIZE 4 | FEMORAL CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.134 | 133211 | 07630030804106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 62 YR | Required Intervention |