UNK
Report
- Report Number
- 1220246-2026-02419
- Event Type
- Injury
- Date Received
- April 24, 2026
- Date of Event
- July 1, 2020
- Report Date
- April 24, 2026
- Manufacturer
- ARTHREX, INC.
- Product Code
- PHX
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- FL, US
- Reporter Occupation
- 501
Narratives
INVESTIGATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE PROVIDED UPON AVAILABILITY OF ADDITIONAL INFORMATION.
ON 02-APR-2026, ARTHREX WAS NOTIFIED VIA EMAIL OF A CASE STUDY PUBLISHED IN 2020 BY THE JOURNAL OF SHOULDER AND ELBOW SURGERY, TITLED ¿SHORT-TERM SAFETY, FUNCTION, AND QUALITY OF LIFE IN PATIENTS TREATED WITH UNIVERS REVERS PROSTHESIS: A MULTICENTER 2-YEAR FOLLOW-UP CASE SERIES". THE STUDY REVIEWED ONE HUNDRED EIGHTY-SEVEN (187) PATIENTS WHO UNDERWENT REVERSE TOTAL SHOULDER ARTHROPLASTY (RTSA), TO ADDRESS PRIMARY DEGENERATIVE SHOULDER OSTEOARTHRITIS OR SECONDARY OSTEOARTHRITIS, EITHER OF WHICH WAS ASSOCIATED WITH INSUFFICIENCY IN THE CENTERING FUNCTION OF THE ROTATOR CUFF OR A MASSIVE ROTATOR CUFF TEAR, OR DIAGNOSIS OF PRIMARY OSTEOARTHRITIS WITH A SEVERE GLENOID DEFECT AND POSTERIOR HUMERAL HEAD SUBLUXATION, USING ARTHREX UNIVERSAL GLENOID DEVICES. DURING THE MINIMUM TWO (2) YEAR FOLLOW-UP PERIOD, ONE (1) PATIENT EXPERIENCED IMPLANT FAILURE / BREAKAGE. SOURCE: SCHWYZER H-K, MARZEL A, WIRTH B, ET AL. SHORT-TERM SAFETY, FUNCTION, AND QUALITY OF LIFE IN PATIENTS TREATED WITH UNIVERS REVERS PROSTHESIS: A MULTICENTER 2-YEAR FOLLOW-UP CASE SERIES. JOURNAL OF SHOULDER AND ELBOW SURGERY. 2020;29(11):2282-2291.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 473982 | UNK | SHOULDR PROSTH, REVERSE CONFIG | PHX | ARTHREX, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | NA | Unknown | Other |