FDA Adverse Event
Injury
Summary report: N
AMISTEM H HA COATED STD STEM SIZE 2
MDR report key: 16502650
·
Received March 8, 2023
Report
- Report Number
- 3005180920-2023-00125
- Event Type
- Injury
- Date Received
- March 8, 2023
- Date of Event
- February 10, 2023
- Report Date
- March 8, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804083
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 13 FEBRUARY 2023: LOT 140005: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 17-MAR-2014. EXPIRATION DATE: 2019-02-28. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 99 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 7 YEARS 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A POTTED STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND THE MEDACTA LINER WITH A MEDACTA LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 164135 | AMISTEM H HA COATED STD STEM SIZE 2 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.132 | 140005 | 07630030804083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention |