FDA Adverse Event
Injury
Summary report: N
STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1
MDR report key: 8064122
·
Received November 13, 2018
Report
- Report Number
- 3005180920-2018-00890
- Event Type
- Injury
- Date Received
- November 13, 2018
- Date of Event
- October 16, 2018
- Report Date
- November 13, 2018
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- UDI-DI
- 07630030802027
- 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 (B)(6) 2018, LOT 121502: 32 ITEMS MANUFACTURED AND RELEASED ON (B)(6) 2012 . EXPIRATION DATE: (B)(6) 2017. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 31 ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
ON (B)(6) 2018 WE WERE INFORMED BY THE SURGEON THAT THE PATIENT FEMORAL STEM WAS LOOSE 6 YEARS AFTER PRIMARY; A REVISION SURGERY WAS BOOKED FOR (B)(6) 2018 TO REMOVE THE STEM AND REPLACE IT WITH A SYNERGY STEM AND A CERAMIC HEAD FROM SMITH AND NEPHEW.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 905051 | STEM: QUADRA-H CEMENTLESS, HA COATED STD STEM SIZE 1 | CEMENTLESS HA HIP STEM | JDI | MEDACTA INTERNATIONAL SA | 121502 | 07630030802027 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 52 YR | Required Intervention |