FDA Adverse Event
Injury
Summary report: N
RESTOR3D RTSA - CUSTOM
MDR report key: 23605587
·
Received November 20, 2025
Report
- Report Number
- 3014833750-2025-00017
- Event Type
- Injury
- Date Received
- November 20, 2025
- Date of Event
- January 15, 2025
- Report Date
- November 18, 2025
- Manufacturer
- RESTOR3D, INC
- Product Code
- PHX
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED DISLOCATION APPROXIMATELY 6 MONTHS FOLLOWING A REVERSE SHOULDER ARTHROPLASTY. THE DEVICE IS NOT PRESENTLY AVAILABLE TO THE MANUFACTURER FOR EVALUATION, AND DUE TO THE AFFECTED COMPONENT BEING RADIOTRANSLUCENT, CONFIRMATION OF THE FAILURE MODE AND SUBSEQUENT COMPLETION OF THE INVESTIGATION WILL TAKE PLACE FOLLOWING REVISION SURGERY.
Description of Event or Problem · 0
IT WAS REPORTED THAT THE PATIENT EXPERIENCED A SHOULDER DISLOCATION APPROXIMATELY 6 MONTHS FOLLOWING SHOULDER ARTHROPLASTY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 2528254 | RESTOR3D RTSA - CUSTOM | REVERSE TOTAL SHOULDER REPLACEMENT | PHX | RESTOR3D, INC | 13219-200,300 | 20250227-FML-27-01 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Required Intervention |