FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 3
MDR report key: 8953729
·
Received September 2, 2019
Report
- Report Number
- 3005180920-2019-00732
- Event Type
- Injury
- Date Received
- September 2, 2019
- Date of Event
- August 5, 2019
- Report Date
- September 2, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804090
- 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 16 AUGUST 2019 LOT 130595: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 12-APR-2013. EXPIRATION DATE: 2018-02-28. 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 AFTER 6 YEARS FROM THE PRIMARY DUE TO PAIN CAUSED BY AN ASEPTIC LOOSENING OF THE STEM. THE SURGEON REVISED THE STEM, HEAD, CUP, AND LINER SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 747858 | STEM: AMISTEM H HA COATED STD STEM SIZE 3 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 130595 | 07630030804090 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |