FDA Adverse Event
Injury
Summary report: N
AMISTEM H FEMORAL STEM
MDR report key: 3080750
·
Received April 8, 2013
Report
- Report Number
- 3006639916-2013-00033
- Event Type
- Injury
- Date Received
- April 8, 2013
- Date of Event
- March 1, 2013
- Report Date
- April 8, 2013
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Distributor report
- Reporter Location
- GM
- Reporter Occupation
- NOT APPLICABLE
Narratives
Description of Event or Problem · 1
PT STARTED COMPLAINING ABOUT PAIN TEN WEEKS AFTER PRIMARY SURGERY WHILE WALKING FAST ON STAIRS. THE REVISION SURGERY WAS PERFORMED 1 YEAR POST OP AND DURING THE SURGERY, IT HAS BEEN REALIZED THAT THE STEM WAS LOOSE SINCE IT CAME OUT EASILY. IT WAS REPORTED THAT THE PT WAS (B)(6), STRONG SMOKER AND DIABETIC. AFTER THE PRIMARY SURGERY, THE WOUND GOT INFECTED AND THE PT TOOK SOME MONTHS TO RECOVER. PLEASE REF MFR REPORT # 3005180920-2013-00033.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 142607 | AMISTEM H FEMORAL STEM | FEMORAL STEM SIZE 5 LAT CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 110834 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |