FDA Adverse Event
Injury
Summary report: N
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK
MDR report key: 7178499
·
Received January 10, 2018
Report
- Report Number
- 3005180920-2018-00820
- Event Type
- Injury
- Date Received
- January 10, 2018
- Date of Event
- December 11, 2017
- Report Date
- January 10, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- UDI-DI
- 07630030802638
- PMA / PMN Number
- K082792
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2018: LOT 162968: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 06 JULY 2016. EXPIRATION DATE: 2021-06-22. NO ANOMALIES FOUND RELATED TO THE ISSUE. 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 EXPERIENCED PAIN AFTER GOING FOR A LONG BUSH WALK. THE STEM HAD SUBSIDED. THE PROXIMAL END OF THE STEM WAS NOT INGROWN SO THE STEM MAY HAVE BEEN MOVING OR TOGGLING, OTHERWISE THE STEM WAS WELL IMPLANTED AND WAS EXTREMELY DIFFICULT TO BE REMOVED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 21404 | QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3, SHORT NECK | CEMENTLESS HIP STEM | JDI | MEDACTA INTERNATIONAL SA | 162968 | 07630030802638 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 55 YR | Required Intervention |