FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM H HA COATED STD STEM SIZE 2
MDR report key: 19392539
·
Received May 24, 2024
Report
- Report Number
- 3005180920-2024-00359
- Event Type
- Injury
- Date Received
- May 24, 2024
- Date of Event
- May 1, 2024
- Report Date
- May 24, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030804083
- 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 08 MAY 2024: LOT 131542: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-JUN-2013. EXPIRATION DATE: 2018-04-30. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL THE ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
THE PATIENT HAD PAIN DUE TO A DISTALLY POTTED STEM AND THE CAUSE IS UNKNOWN. AT 10 YEARS AND 9 MONTHS POST PRIMARY THE SURGEON REVISED THE STEM AND HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2304349 | STEM: AMISTEM H HA COATED STD STEM SIZE 2 | HIP CEMENTLESS COATED STEM | LZO | MEDACTA INTERNATIONAL SA | 131542 | 07630030804083 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 83 YR | Female | Required Intervention |