FDA Adverse Event
Injury
Summary report: N
AMISTEM H, HA COATED STEM SIZE 5 STD
MDR report key: 6944540
·
Received October 12, 2017
Report
- Report Number
- 3005180920-2017-00576
- Event Type
- Injury
- Date Received
- October 12, 2017
- Date of Event
- September 12, 2017
- Report Date
- October 12, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804113
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 152133: (B)(4) ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2015. EXPIRATION DATE: 2020-05-31. 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.
Description of Event or Problem · 1
THE PATIENT CAME IN COMPLAINING OF PAIN. THE SURGEON DETERMINED THE STEM WAS LOOSE. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 724924 | AMISTEM H, HA COATED STEM SIZE 5 STD | CEMENTLESS FEMORAL STEM | LZO | MEDACTA INTERNATIONAL SA | 152133 | 07630030804113 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |