FDA Adverse Event
Injury
Summary report: N
AMISTEM H FEMORAL STEM
MDR report key: 2877392
·
Received December 14, 2012
Report
- Report Number
- 3005180920-2012-00087
- Event Type
- Injury
- Date Received
- December 14, 2012
- Date of Event
- October 25, 2012
- Report Date
- December 14, 2012
- Manufacturer
- MEDACTA INTERNATIONAL, SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FR
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 2 STD - (B)(4)/ LOT 092767 (60 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECS VALID AT THE TIME OF MFG, INCLUDED WASHING AND STERILIZATION CYCLES. ALL THE STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO OTHER INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATE COLLECTED, THE CAUSE OF THE LOOSENING IS UNK AND WE DO NOT HAVE EVIDENCE THAT THE EVENT IS DEVICE RELATED; THIS IS A KNOWN COMPLICATION OF THR.
Description of Event or Problem · 1
REVISION SURGERY DUE TO LOOSENING OF THE STEM 29 MONTHS POST OP. WE WERE INFORMED ON (B)(6) 2012 ONLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AMISTEM H FEMORAL STEM | FEMORAL STEM SIZE 2 STANDARD CEMENTLESS | LZO | MEDACTA INTERNATIONAL, SA | 092767 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention |