FDA Adverse Event
Injury
Summary report: N
OVERTURETI KNEE RESURFACING SYSTEM
MDR report key: 24012499
·
Received January 8, 2026
Report
- Report Number
- 3027737826-2026-00001
- Event Type
- Injury
- Date Received
- January 8, 2026
- Date of Event
- December 15, 2025
- Report Date
- January 8, 2026
- Manufacturer
- OVERTURE ORTHOPAEDICS
- Product Code
- HSX
- PMA / PMN Number
- K221292
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 0
OVERTURE BECAME AWARE OF A PUBLICLY AVAILABLE SOCIAL MEDIA POST AUTHORED BY A SURGEON WHO REMOVED AND REVISED AN IMPLANT TO A UNICOMPARTMENTAL KNEE ARTHROPLASTY (UKA). THE SURGEON ALLEGED "LOOSENING OF THE IMPLANT." THE ORIGINAL IMPLANTATION REPORTEDLY OCCURRED APPROXIMATELY IN (B)(6) 2025. AN IMAGE OF THE EXPLANTED DEVICE WAS INCLUDED IN THE POST. BASED ON VISUAL REVIEW, THE COMPONENT APPEARS SIMILAR TO A ROUND FEMORAL OVERTURETI COMPONENT; HOWEVER, THE DEVICE IDENTITY COULD NOT BE CONFIRMED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 67732 | OVERTURETI KNEE RESURFACING SYSTEM | PROSTHESIS, KNEE, FEMOROTIBIAL, NON-CONSTRAINED, CEMENTED, METAL/POLYMER | HSX | OVERTURE ORTHOPAEDICS |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |