FDA Adverse Event
Injury
Summary report: N
AMISTEM H, HA COATED STEM SIZE 7 STD
MDR report key: 6141274
·
Received December 2, 2016
Report
- Report Number
- 3005180920-2016-00632
- Event Type
- Injury
- Date Received
- December 2, 2016
- Date of Event
- November 4, 2016
- Report Date
- December 2, 2016
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 25 NOVEMBER 2016. LOT 161465: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 JUNE 2016. EXPIRATION DATE: 2021-05-29. 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. NOT EXPLANTED.
Description of Event or Problem · 1
DURING A PRIMARY HIP SURGERY, WHEN THE SURGEON WAS INSERTING THE STEM, THE FEMUR FRACTURED. THE SURGEON CABLED THE FRACTURE TO STABILIZE THE FEMUR (THE STEM WAS LEFT IN PLACE). THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 793185 | AMISTEM H, HA COATED STEM SIZE 7 STD | CEMENTLESS FEMORAL STEM | LZO | MEDACTA INTERNATIONAL SA | 161465 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Other |