FDA Adverse Event
Injury
Summary report: N
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50
MDR report key: 18109427
·
Received November 10, 2023
Report
- Report Number
- 3005180920-2023-00881
- Event Type
- Injury
- Date Received
- November 10, 2023
- Date of Event
- October 12, 2023
- Report Date
- November 10, 2023
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030860966
- PMA / PMN Number
- K143453
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MO, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 24 OCTOBER 2023: LOT 2206892: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2022. EXPIRATION DATE: 2027-09-13. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, ALL 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 AT ABOUT 1 YEAR FOR SHELL LOOSENING. THE SHELL, LINER AND HEAD HAVE BEEN REVISED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1806208 | CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø50 | HIP DOUBLE MOBILITY CEMENTLESS ACETABULAR SHELL | LPH | MEDACTA INTERNATIONAL SA | 2206892 | 07630030860966 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 69 YR | Female | Required Intervention |