FDA Adverse Event
Injury
Summary report: N
CUPULE MOBILE A BAGUE
MDR report key: 24735737
·
Received March 30, 2026
Report
- Report Number
- 3010536692-2026-00068
- Event Type
- Injury
- Date Received
- March 30, 2026
- Report Date
- May 22, 2026
- Manufacturer
- MICROPORT ORTHOPEDICS INC.
- Product Code
- LZO
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IT
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
THIS EVENT WILL BE UPDATED ONCE THE INVESTIGATION IS COMPLETE. TRENDS WILL BE EVALUATED.
Description of Event or Problem · 0
AD HOC REPORT FROM (B)(6) ITALY REPORTS THE USAGE OF 2391 CASES OF THE BIPOLAR CUP IMPLANTED IN WITH COCR FEMORAL HEADS IN HEMIARTHROPLASTY. THERE WERE 45 REVISIONS FOR THE FOLLOWING REASONS: DISLOCATION:23.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 400342 | CUPULE MOBILE A BAGUE | HIP COMPONENT | LZO | MICROPORT ORTHOPEDICS INC. | PPT170XX | NI |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |