FDA Adverse Event
Injury
Summary report: N
AISTEM H FEMORAL STEM
MDR report key: 2773665
·
Received September 26, 2012
Report
- Report Number
- 3005180920-2012-00057
- Event Type
- Injury
- Date Received
- September 26, 2012
- Date of Event
- August 24, 2012
- Report Date
- September 26, 2012
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- NOT APPLICABLE
Narratives
Additional Manufacturer Narrative · 1
DOCUMENT REVIEW: AMISTEM H FEMORAL STEM SIZE 2 STD - (B)(4) / LOT 113182 (25 STEMS PRODUCED). ALL PARAMETERS WERE FOUND TO BE IN ACCORDANCE WITH THE SPECIFICATIONS VALID AT THE TIME OF MANUFACTURING, INCLUDED WASHING AND STERILIZATION CYCLES. THE 24 STEMS BELONGING TO THIS LOT HAVE BEEN ALREADY IMPLANTED AND NO INCIDENTS HAVE BEEN REPORTED UP TO NOW. FROM THE DATA COLLECTED, THE CAUSE OF THE LOOSENING IS UNK AND WE DO NOT HAVE EVIDENCES THAT THE EVENT IS DEVICE RELATED; STEM LOOSENING IS A KNOWN COMPLICATIONS OF THR.
Description of Event or Problem · 1
THE AMISTEM WAS TOO LOOSE IN THE BONE: A REVISION SURGERY WAS PERFORMED TO SUBSTITUTE STEM, CERAMIC BALL HEAD AND CERAMIC LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | AISTEM H FEMORAL STEM | FEMORAL STEM SIZE 2 STANDARD | LZO | MEDACTA INTERNATIONAL SA | 113182 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK | Required Intervention | CERAMIC BALL HEADS| LINER NOT MARKETES IN USA |