Humeris Shoulder 316-0016Recalls & reported problems
Fx Solutions · HUMERIS STEM TA6V SIZE 16 CEMENTLESS Ti/HA · Class 2 · Implant
All models of Humeris Shoulder (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03701037303689), received between Dec 30, 2021 and Jan 28, 2022 — classified as 2 injuries.
Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.
Most reported problems
Device problems
- Appropriate Device Problem Term/Code Not Available2
Patient problems
- Failure of Implant1
- Insufficient Information1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryJan 28, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 4 MONTHS AFTER THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO FAILURE IN THE REPAIR OF THE ROTATOR CUFF. A HUMERIS STEM CEMENTLESS (16), DOUBLE TAPER, 3-4 PEGS GLENOID AND COCR HEAD (50X20) WERE EXPLANTED. A GLENOID BASEPLATE (24), CENTERED GLENOSPHERE (40/10) AND POST EXTENSION CEMENTLESS (6) WERE IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13385165 ↗InjuryDec 30, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO FAILURE IN THE REPAIR OF THE ROTATOR CUFF. THE PATIENT WAS INITIALLY IMPLANTED WITH HUMERIS ANATOMICAL WHICH WAS THEN REVISED TO REVERSE CONFIGURATION. A DOUBLE TAPER, 3-4 PEGS GLENOID AND COCR HEAD (50X20) WERE EXPLANTED. A GLENOID BASEPLATE (24), CENTERED GLENOSPHERE (40/10), POST EXTENSION CEMENTLESS (6), HUMERAL CUP (40/3), 2 STANDARD SCREWS (25 MM AND 35 MM EACH) AND 2 LOCKING SCREWS ( 20 MM AND 25 MM EACH) WERE IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 13122151 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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