FDA Adverse Event
Injury
Summary report: N
AMISTEM H HA COATED STEM SIZE 7
MDR report key: 8464660
·
Received March 29, 2019
Report
- Report Number
- 3005180920-2019-00204
- Event Type
- Injury
- Date Received
- March 29, 2019
- Date of Event
- February 27, 2019
- Report Date
- March 29, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804137
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 25 MARCH 2019: LOT 110840: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-MAY-2011. EXPIRATION DATE: 2016-03-31. 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 PERFORMED 6 YEARS AND 11 MONTHS AFTER PRIMARY SURGERY DUE TO PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE STEM. THE SURGEON REVISED THE STEM AND THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 258714 | AMISTEM H HA COATED STEM SIZE 7 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 110840 | 07630030804137 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |