FDA Adverse Event
Injury
Summary report: N
QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK
MDR report key: 7153833
·
Received December 29, 2017
Report
- Report Number
- 3005180920-2017-00795
- Event Type
- Injury
- Date Received
- December 29, 2017
- Date of Event
- December 1, 2017
- Report Date
- December 29, 2017
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- UDI-DI
- 07630030802614
- PMA / PMN Number
- K082792
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON (B)(6) 2017. LOT 162966: 85 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2016. EXPIRATION DATE: (B)(6) 2021. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 76 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
THE PATIENT HAD PAIN 14 MONTHS AFTER PRIMARY. DURING THE REVISION SURGERY IT WAS NOTICED THAT THE STEM HAD LOOSENED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 934725 | QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1, SHORT NECK | 01.12.21SN | JDI | MEDACTA INTERNATIONAL SA | 162966 | 07630030802614 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |