FDA Adverse Event
Injury
Summary report: N
AMISTEM H CEMENTLESS FEMORAL STEM SIZE 2 LAT
MDR report key: 5267514
·
Received December 4, 2015
Report
- Report Number
- 3005180920-2015-00304
- Event Type
- Injury
- Date Received
- December 4, 2015
- Date of Event
- November 5, 2015
- Report Date
- March 3, 2016
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
ON 03 FEBRUARY 2016 IT WAS PREPARED A FINAL REPORT WITH THE INFORMATION ALREADY SUBMITTED IN THE INTIAL REPORT. ON 05 FEBRUARY 2016 THE REPORT WAS SENT TO THE INITIAL REPORTER AND THE CASE WAS CLOSED.
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 04 DECEMBER 2015: LOT 102664: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22 SEPTEMBER 2010. EXPIRATION DATE: 2015-08-31. 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. NO INFORMATION RECEIVED YET.
Description of Event or Problem · 1
REVISION OF AMIS STEM DUE TO STRESS SHIELDING , PLANNED ON (B)(6) 2015.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 796954 | AMISTEM H CEMENTLESS FEMORAL STEM SIZE 2 LAT | FEMORAL CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 102664 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |