FDA Adverse Event
Injury
Summary report: N
STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM #SIZE5
MDR report key: 10741394
·
Received October 27, 2020
Report
- Report Number
- 3005180920-2020-00748
- Event Type
- Injury
- Date Received
- October 27, 2020
- Date of Event
- September 28, 2020
- Report Date
- October 27, 2020
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- JDI
- UDI-DI
- 07630030802171
- 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 01 OCTOBER 2020: LOT 130165: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 13-MAR-2013. EXPIRATION DATE: 2018-02-28. 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
REVISION SURGERY 6 YEARS AND 1 MONTH AFTER PRIMARY FOR FEMORAL STEM LOOSENING. STEM AND HEAD REVISED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1207525 | STEM: QUADRA-H CEMENTLESS, HA COATED LAT STEM #SIZE5 | HIP CEMENTLESS STEM | JDI | MEDACTA INTERNATIONAL SA | 01.12.035 | 130165 | 07630030802171 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |