FDA Adverse Event
Injury
Summary report: N
AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 3
MDR report key: 13392086
·
Received January 31, 2022
Report
- Report Number
- 3005180920-2022-00056
- Event Type
- Injury
- Date Received
- January 31, 2022
- Date of Event
- January 4, 2022
- Report Date
- January 31, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804588
- PMA / PMN Number
- K121011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 05 JANUARY 2022: LOT 140730: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 31-MAR-2014. EXPIRATION DATE: 2019-FEB-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 0
AT 7 YEARS AND 1 MONTH FROM PRIMARY, THE SURGEON PERFORMED A REVISION SURGERY FOR STEM LOOSENING. STEM, HEAD AND LINER REVISED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 844853 | AMISTEM COLLARED STEM COLLARED HA COATED STD STEM SIZE 3 | HIP STEM CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 01.18.233 | 140730 | 07630030804588 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |