FDA Adverse Event
Injury
Summary report: N
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK
MDR report key: 10697594
·
Received October 19, 2020
Report
- Report Number
- 3005180920-2020-00724
- Event Type
- Injury
- Date Received
- October 19, 2020
- Date of Event
- September 28, 2020
- Report Date
- October 19, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- UDI-DI
- 07630030802607
- PMA / PMN Number
- K082792
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- BE
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2020. LOT 1905425: 50 ITEMS MANUFACTURED AND RELEASED ON 08-OCT-2019. EXPIRATION DATE: 2024-09-24. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 21 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
PRIMARY SURGERY PERFORMED SUCCESSFULLY IN THE MORNING. IN THE AFTERNOON THE SURGEON NOTICED THAT THE PATIENT WAS IN PAIN AND LEGG WAS SHORTER THAN THE OTHER SUDDENLY. HE TOOK A CT WHERE THE STEM WAS SUBSIDED AND IT SHOWED A PERI PROSTHETIC FRACTURE, SUBSIDENCE HAPPENED AFTER CAUSING THE FRACTURE. PATIENT HAS A VERY OSTEOPOROTIC BONE QUALITY. REVISION SURGERY PERFORMED 7 DAYS AFTER PRIMARY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1164974 | STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 0, SHORT NECK | HIP CEMENTLESS STEM | JDI | MEDACTA INTERNATIONAL SA | 01.12.20SN | 1905425 | 07630030802607 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 73 YR | Required Intervention |