FDA Adverse Event
Injury
Summary report: N
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 54
MDR report key: 11804821
·
Received May 11, 2021
Report
- Report Number
- 3005180920-2021-00367
- Event Type
- Injury
- Date Received
- May 11, 2021
- Date of Event
- April 12, 2021
- Report Date
- May 11, 2021
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030860980
- PMA / PMN Number
- K143453
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 1
BATCH REVIEW PERFORMED ON 19 APRIL 2021. LOT 1904334: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 30-OCT-2019. EXPIRATION DATE: 2024-10-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN ALREADY SOLD WITHOUT ANY OTHER SIMILAR REPORTED EVENT.
Description of Event or Problem · 1
REVISION SURGERY 6 MONTHS AFTER PRIMARY DUE TO CUP MIGRATION. ALL COMPONENTS REVISED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 702199 | CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL 54 | DOUBLE MOBILITY ACETABULAR SHELL | LPH | MEDACTA INTERNATIONAL SA | 01.32.154MB | 1904334 | 07630030860980 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Required Intervention |