FDA Adverse Event
Injury
Summary report: N
AMISTEM-H PROXIMAL COATING LAT STEM SIZE 4
MDR report key: 7968809
·
Received October 16, 2018
Report
- Report Number
- 3005180920-2018-00795
- Event Type
- Injury
- Date Received
- October 16, 2018
- Date of Event
- September 18, 2018
- Report Date
- October 16, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804496
- PMA / PMN Number
- K161635
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SZ
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 16 OCTOBER 2018. LOT 163715: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 JULY 2016. EXPIRATION DATE: 2021-07-04. 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
REVISION SURGERY PERFORMED DUE TO STEM LOOSENING ONE YEAR AND 8 MONTHS AFTER PRIMARY SURGERY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 808970 | AMISTEM-H PROXIMAL COATING LAT STEM SIZE 4 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 163715 | 07630030804496 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |