FDA Adverse Event
Injury
Summary report: N
QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD, SHORT NECK
MDR report key: 6202218
·
Received December 23, 2016
Report
- Report Number
- 3005180920-2016-00678
- Event Type
- Injury
- Date Received
- December 23, 2016
- Date of Event
- November 23, 2016
- Report Date
- December 23, 2016
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- 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) 2016. LOT 152222: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 26 AUGUST 2015. EXPIRATION DATE: 2020-08-15. 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 HAD A MEDIAL CALCAR FRACTURE. STEM, HEAD AND LINER WERE REVISED. THE REVISION SURGERY WAS SUCCESSFULLY COMPLETED. PIECES EXPLANTED ARE NOT AVAILABLE FOR FURTHER INVESTIGATION.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 852459 | QUADRA-H CEMENTLESS, HA COATED STEM SIZE 3 STD, SHORT NECK | CEMENTLESS FEMORAL STEM | JDI | MEDACTA INTERNATIONAL SA | 152222 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Required Intervention |