FDA Adverse Event
Injury
Summary report: N
STEM: QUADRA-P QUADRA-P SHORT NECK STD STEM SIZE 2
MDR report key: 10920018
·
Received November 30, 2020
Report
- Report Number
- 3005180920-2020-00846
- Event Type
- Injury
- Date Received
- November 30, 2020
- Date of Event
- November 2, 2020
- Report Date
- November 30, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630971243439
- PMA / PMN Number
- K192827
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 12 NOVEMBER 2020: LOT 1910215: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-APR-2020. EXPIRATION DATE: 2025-04-14. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT CAME IN, 18 DAYS AFTER PRIMARY SURGERY, REPORTING PAIN DUE TO A SUBSIDED STEM. THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM AND HEAD AND THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1387969 | STEM: QUADRA-P QUADRA-P SHORT NECK STD STEM SIZE 2 | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 01.12.252 | 1910215 | 07630971243439 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 67 YR | Required Intervention |