FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED LAT STEM SIZE 0
MDR report key: 16276132
·
Received February 1, 2023
Report
- Report Number
- 3005180920-2023-00034
- Event Type
- Injury
- Date Received
- February 1, 2023
- Date of Event
- January 13, 2023
- Report Date
- February 1, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804168
- PMA / PMN Number
- K121011
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON (B)(6) 2023. LOT 140021: 20 ITEMS MANUFACTURED AND RELEASED ON 14-MAR-2014. EXPIRATION DATE: 2019-01-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 13 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 6 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 THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775245 | STEM: AMISTEM H HA COATED LAT STEM SIZE 0 | HIP STEM CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 01.18.140 | 140021 | 07630030804168 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |