FDA Adverse Event
Injury
Summary report: N
CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES
MDR report key: 17181791
·
Received June 22, 2023
Report
- Report Number
- 3005180920-2023-00435
- Event Type
- Injury
- Date Received
- June 22, 2023
- Date of Event
- May 23, 2023
- Report Date
- June 22, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030810794
- PMA / PMN Number
- K132879
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 26 MAY 2023:LOT 2011711: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 03-FEB-2021. EXPIRATION DATE: 2026-01-(B)(4). NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, 97 ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT IN THE PERIOD OF REVIEW.
Description of Event or Problem · 0
REVISION SURGERY FOR MPACT DH LOOSENING 1 YEAR AND 11 MONTHS POST-PRIMARY. THE SHELL, LINER AND HEAD HAVE BEEN REVISED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1062434 | CUP: MPACT ACETABULAR SHELL Ø52 TWO-HOLES | ACETABULAR CUP | LPH | MEDACTA INTERNATIONAL SA | 01.32.152DH | 2011711 | 07630030810794 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |