FDA Adverse Event
Injury
Summary report: N
AMISTEM H, HA COATED STEM SIZE 2 STD
MDR report key: 7037284
·
Received November 16, 2017
Report
- Report Number
- 3005180920-2017-00664
- Event Type
- Injury
- Date Received
- November 16, 2017
- Date of Event
- October 17, 2017
- Report Date
- November 16, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804083
- 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 13 NOVEMBER 2017. LOT 161429: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16 JUNE 2016. EXPIRATION DATE: 2021-05-19. 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 THAT THE STEM HAD SHIFTED. THE PATIENT WAS OVERWEIGHT WHICH MAY HAVE CAUSED THE SHIFT. THE SURGEON REVISED THE STEM, HEAD AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 816978 | AMISTEM H, HA COATED STEM SIZE 2 STD | CEMENTLESS FEMORAL STEM | LZO | MEDACTA INTERNATIONAL SA | 161429 | 07630030804083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |