FDA Adverse Event
Injury
Summary report: N
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
MDR report key: 15631723
·
Received October 19, 2022
Report
- Report Number
- 3005180920-2022-00788
- Event Type
- Injury
- Date Received
- October 19, 2022
- Date of Event
- September 29, 2022
- Report Date
- October 19, 2022
- Manufacturer
- MEDACTA INTERNATIONAL SA
- Product Code
- LPH
- UDI-DI
- 07630030860959
- PMA / PMN Number
- K143453
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- 003
Narratives
Additional Manufacturer Narrative · 0
BATCH REVIEW PERFORMED ON 06 OCTOBER 2022. LOT 2100559: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 23-JUNE-2021. EXPIRATION DATE: 2026-05-19. NO ANOMALIES FOUND RELATED TO THE PROBLEM. TO DATE, (B)(4) ITEMS OF THE SAME LOT HAVE BEEN SOLD WITHOUT ANY SIMILAR REPORTED EVENT DURING THE PERIOD OF REVIEW.
Description of Event or Problem · 0
AT ABOUT 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE SURGEON OBSERVED THAT THE CUP WAS ANTEVERTED. THE SURGEON REVISED THE MEDACTA CUP AND LINER WITH COMPETITOR COMPONENTS AND REVISED THE MEDACTA HEAD WITH A MEDACTA HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2938940 | CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 | DOUBLE MOBILITY CUP | LPH | MEDACTA INTERNATIONAL SA | 01.32.148MB | 2100559 | 07630030860959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |