Humeris Shoulder 316-0008Recalls & reported problems
Fx Solutions · HUMERIS STEM TA6V SIZE 08 CEMENTLESS Ti/HA · Class 2 · Implant
All models of Humeris Shoulder (9)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03701037301531), received between Feb 18, 2021 and Sep 3, 2024 — classified as 3 injuries.
The most frequently reported specific device problem is “Microbial Contamination of Device” (1 report).
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 16, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Microbial Contamination of Device1
Patient problems
- Erosion1
- Impotence1
- Joint Dislocation1
- Medical device site infection1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjurySep 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP, A GLÉNOSPHÈRE AND A STEM WERE EXPLANTED. A CUP, A GLÉNOSPHÈRE AND A STEM WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 20124913 ↗InjuryJun 16, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP, A GLENOSPHERE, A METAGLENE,A STEM, SCREWS AND SMARTAPE WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A STEM, SCREWS AND POST EXTENSION WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17141844 ↗InjuryFeb 18, 2021Adverse Event Without Identified Device or Use Problem
REMOVAL OF AN ANATOMICAL HUMERIS PLACED MANY YEARS AGO BECAUSE OF SIGNIFICANT GLENOIDITIS AND FUNCTIONAL IMPOTENCE OF THE PATIENT. THIS DAY, A REVERSED HUMELOCK 2 IS PLACED.
Patient problems: Erosion; Impotence
MAUDE report 11342644 ↗
Other Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page