FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H 01.18.131 HA COATED STD STEM SIZE 1
MDR report key: 16783325
·
Received April 21, 2023
Report
- Report Number
- 3005180920-2023-00261
- Event Type
- Injury
- Date Received
- April 21, 2023
- Date of Event
- March 23, 2023
- Report Date
- April 21, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804076
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 24-MAR-2023. LOT 131627: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 22-JUL-2013. EXPIRATION DATE: 2018-05-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 9 YEARS AND 5 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE STEM AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE MEDACTA STEM AND HEAD WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA LINER WITH A MEDACTA LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 791607 | STEM: AMISTEM H 01.18.131 HA COATED STD STEM SIZE 1 | HIP HA COATED STD STEM | LZO | MEDACTA INTERNATIONAL SA | 01.18.131 | 131627 | 07630030804076 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |