FDA Adverse Event
Injury
Summary report: N
EQUINOXE REVERSE 42MM HUMERAL LINER +2.5
MDR report key: 17462236
·
Received August 4, 2023
Report
- Report Number
- 1038671-2023-01864
- Event Type
- Injury
- Date Received
- August 4, 2023
- Date of Event
- June 23, 2023
- Report Date
- October 14, 2025
- Manufacturer
- EXACTECH, INC.
- Product Code
- KWT
- PMA / PMN Number
- K063569
- Adverse Event
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- US
- Reporter Occupation
- PHYSICIAN
- Health Professional
- Yes
Narratives
Additional Manufacturer Narrative · 0
D10. CONCOMITANTS: HUMERAL STEM OR STEMLESS. REVERSE HUMERAL TRAY 3201005. REVERSE GLENOSPHERE 3200842.
Description of Event or Problem · 0
IT WAS REPORTED VIA CLINICAL STUDY, THAT APPROXIMATELY 2 YEARS POSTOP THE INITIAL IMPLANT, THIS 71 YO MALE PATIENT WAS REVISED DUE TO DISASSOCIATION OF POLYETHYLENE. THE PATIENT WOKE UP IN LATE MAY WITH DISLOCATED SHOULDER. THE OUTCOME WAS LAST KNOWN AS RESOLVED. THE CASE REPORT FORM INDICATES THIS EVENT IS DEFINITELY RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DEVICES WILL NOT BE RETURNED. REVERSE HUMERAL LINER 3204203. 510K: K063569, KWT, (B)(4).
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 952515 | EQUINOXE REVERSE 42MM HUMERAL LINER +2.5 | PROSTHESIS, SHOULDER, NON-CONSTRAINED, METAL/POLYMER CEMENTED | KWT | EXACTECH, INC. | UNK | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 71 YR | Male | Other| R | SEE H10. |