FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED LAT STEM SIZE 6
MDR report key: 8478392
·
Received April 3, 2019
Report
- Report Number
- 3005180920-2019-00238
- Event Type
- Injury
- Date Received
- April 3, 2019
- Date of Event
- March 6, 2019
- Report Date
- April 3, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804229
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 01 APRIL 2019: LOT 150150: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-APR-2015. EXPIRATION DATE: 2020-03-31. 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
REVISION SURGERY, 1 YEAR AND 4 MONTHS AFTER PRIMARY, DUE TO STEM SUBSIDENCE. THE SURGEON REVISED THE STEM AND HEAD WITH ANOTHER COMPANY'S PRODUCT AND REVISED THE LINER WITH A MEDACTA LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 272542 | STEM: AMISTEM H HA COATED LAT STEM SIZE 6 | UNCEMENTED HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 150150 | 07630030804229 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |