FDA Adverse Event
Injury
Summary report: N
STEM: QUADRA-P STD STEM SIZE 2
MDR report key: 18171358
·
Received November 20, 2023
Report
- Report Number
- 3005180920-2023-00897
- Event Type
- Injury
- Date Received
- November 20, 2023
- Date of Event
- October 26, 2023
- Report Date
- November 20, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630040720434
- PMA / PMN Number
- K181254
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 30 OCTOBER 2023: LOT 2302601: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 24-MAY-2023. EXPIRATION DATE: 2028-05-06. 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
REVISION FOR QUADRA P SUBSIDENCE, 3 MONTHS AFTER PRIMARY. THE STEM THE HEAD AND THE LINER HAVE BEEN REVISED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1992758 | STEM: QUADRA-P STD STEM SIZE 2 | CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 2302601 | 07630040720434 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 59 YR | Male | Required Intervention |