FDA Adverse Event
Injury
Summary report: N
STEM: AMISTEM-P COLLARED LAT STEM SIZE 2
MDR report key: 16276131
·
Received February 1, 2023
Report
- Report Number
- 3005180920-2023-00029
- Event Type
- Injury
- Date Received
- February 1, 2023
- Date of Event
- January 12, 2023
- Report Date
- February 1, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720311
- PMA / PMN Number
- K173794
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 13 JANUARY 2023. LOT 1903242: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 10-JULY-2019. EXPIRATION DATE: 2024-06-25. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) 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 2 YEARS 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND INSTABILITY. X-RAYS SHOWED A PEDESTAL FORMATION AT THE DISTAL TIP OF THE STEM. IN ADDITION, RADIOLUCENCY WAS NOTED AROUND THE PROXIMAL PORTION OF THE STEM. THE SURGEON REVISED THE STEM, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 775244 | STEM: AMISTEM-P COLLARED LAT STEM SIZE 2 | HIP STEM CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 01.18.442 | 1903242 | 07630040720311 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |