FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 4
MDR report key: 9579976
·
Received January 13, 2020
Report
- Report Number
- 3005180920-2019-01147
- Event Type
- Injury
- Date Received
- January 13, 2020
- Date of Event
- December 18, 2019
- Report Date
- January 13, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804106
- 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 27-DEC-2019. LOT 132636: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 04-SEP-2013. EXPIRATION DATE: 31.07.2018. 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.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A PERI-PROSTHETIC FRACTURE OF THE FEMUR 6 YEARS AFTER PRIMARY. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND CABLED THE FRACTURE. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 44922 | STEM: AMISTEM H HA COATED STD STEM SIZE 4 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 132636 | 07630030804106 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |