FDA Adverse Event
Injury
Summary report: N
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3
MDR report key: 9464997
·
Received December 13, 2019
Report
- Report Number
- 3005180920-2019-01078
- Event Type
- Injury
- Date Received
- December 13, 2019
- Date of Event
- November 28, 2019
- Report Date
- December 13, 2019
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- UDI-DI
- 07630030802041
- PMA / PMN Number
- K082792
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 29 NOVEMBER 2019: LOT 132658: 60 ITEMS MANUFACTURED AND RELEASED ON 13-SEP-2013. EXPIRATION DATE: 2018-08-31. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE STEM AND THE HEAD WERE REMOVED DUE TO LOOSENING AND REPLACED WITH COMPETITOR ITEMS ALMOST 5 YEARS AND 9 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1262706 | STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 3 | HIP CEMENTLESS STEM | JDI | MEDACTA INTERNATIONAL SA | 132658 | 07630030802041 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 58 YR | Required Intervention |