FDA Adverse Event
Injury
Summary report: N
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7, SHORT NECK
MDR report key: 11840660
·
Received May 18, 2021
Report
- Report Number
- 3005180920-2021-00398
- Event Type
- Injury
- Date Received
- May 18, 2021
- Date of Event
- April 20, 2021
- Report Date
- May 18, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030802676
- PMA / PMN Number
- K093944
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 30 APRIL 2021 LOT 173162: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 28-NOV-2017. EXPIRATION DATE: 2022-11-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 12 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY PERFORMED DUE TO STEM MOBILIZATION 2 YEARS 7 MONTHS AFTER THE PRIMARY. STEM AND LINER SUCCESSFULLY REVISED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 736876 | STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 7, SHORT NECK | CEMENTLESS HIP STEM | LZO | MEDACTA INTERNATIONAL SA | 01.12.27SN | 173162 | 07630030802676 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |