FDA Adverse Event
Injury
Summary report: N
STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM SIZE 7
MDR report key: 16417235
·
Received February 22, 2023
Report
- Report Number
- 3005180920-2023-00071
- Event Type
- Injury
- Date Received
- February 22, 2023
- Date of Event
- January 25, 2023
- Report Date
- February 22, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030885679
- PMA / PMN Number
- K151531
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 27 JANUARY 2023: LOT 2000312: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26-MAY-2020. EXPIRATION DATE: 2025-05-17. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
DURING THE FIRST RECOVERY DAY, A FEMUR FRACTURE WAS DETECTED. AT 1 DAY FROM THR THE SURGEON REVISED THE STEM AND HEAD.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1320050 | STEM: MASTERLOC 01.39.207 CEMENTLESS TI COATED LAT STEM SIZE 7 | HIP CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 01.39.207 | 2000312 | 07630030885679 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Male | Required Intervention |