FDA Adverse Event
Injury
Summary report: N
STEM: QUADRA-C CEMENTED, MIRROR POLISHING LAT STEM SIZE 2 12/14
MDR report key: 19040598
·
Received April 4, 2024
Report
- Report Number
- 3005180920-2024-00164
- Event Type
- Injury
- Date Received
- April 4, 2024
- Date of Event
- March 6, 2024
- Report Date
- April 4, 2024
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LZO
- UDI-DI
- 07630030802317
- PMA / PMN Number
- K083558
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- AS
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 11 MARCH 2024: LOT 170904: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-APR-2017. EXPIRATION DATE: 2022-03-27. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITH NO SIMILAR REPORTED CASE DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT 5 YEARS AND 10 MONTHS FROM THE PRIMARY, REVISION SURGERY DUE TO STEM SUBSIDENCE AND CONSEQUENT LOOSENING. STEM, HEAD AND LINER SUCCESSFULLY REVISED WITH COMPETITORS IMPLANTS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 70973 | STEM: QUADRA-C CEMENTED, MIRROR POLISHING LAT STEM SIZE 2 12/14 | CEMENTLESS STEM | LZO | MEDACTA INTERNATIONAL SA | 170904 | 07630030802317 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 72 YR | Female | Required Intervention |