FDA Adverse Event
Injury
Summary report: N
CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48
MDR report key: 16467465
·
Received March 2, 2023
Report
- Report Number
- 3005180920-2023-00090
- Event Type
- Injury
- Date Received
- March 2, 2023
- Date of Event
- February 2, 2023
- Report Date
- March 2, 2023
- 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 03 FEBRUARY 2023. LOT 2206557: (B)(4) ITEMS MANUFACTURED AND RELEASED ON 05-OCT-2022. EXPIRATION DATE: 2027-09-13. 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 3 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN TO A LOOSE CUP. THE SURGEON REVISED THE CUP, HEAD, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2002564 | CUP: MPACT DOUBLE MOBILITY ACETABULAR SHELL Ø48 | HIP DOUBLE MOBILITY CUP | LPH | MEDACTA INTERNATIONAL SA | 01.32.148MB | 2206557 | 07630030860959 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Female | Required Intervention |