FDA Adverse Event
Injury
Summary report: N
QUADRA-P SHORT NECK LAT STEM SIZE 2
MDR report key: 13280937
·
Received January 18, 2022
Report
- Report Number
- 3005180920-2022-00021
- Event Type
- Injury
- Date Received
- January 18, 2022
- Date of Event
- December 20, 2021
- Report Date
- January 18, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630971243545
- PMA / PMN Number
- K192827
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 23 DECEMBER 2021. LOT 1910222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 16-APR-2020. EXPIRATION DATE: 2025-APR-06. NO ANOMALIES WERE FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT SIMILAR REPORTED EVENTS.
Description of Event or Problem · 0
THE PATIENT CAME IN 1 MONTH AFTER THE PRIMARY REPORTING PAIN DUE TO A SUBSIDED STEM AND THE CAUSE OF THE SUBSIDED STEM IS UNKNOWN. THE SURGEON REVISED THE STEM, HEAD AND LINER.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 122676 | QUADRA-P SHORT NECK LAT STEM SIZE 2 | HIP STEM CEMENTLESS | LZO | MEDACTA INTERNATIONAL SA | 01.12.272 | 1910222 | 07630971243545 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |