Humeris Shoulder 316-0014Recalls & reported problems
Fx Solutions · HUMERIS STEM TA6V SIZE 14 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
- 7
- Deaths reported
- 0
- Injuries reported
- 7
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03701037301593), received between Jul 9, 2021 and Sep 9, 2026 — classified as 7 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).
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 Problem4
- Device Dislodged or Dislocated2
- Appropriate Device Problem Term/Code Not Available1
- Microbial Contamination of Device1
Patient problems
- Joint Laxity2
- Medical device site infection2
- Bone Fracture(s)1
- Insufficient Information1
- Unspecified Infection1
Recent adverse event reports
The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.
InjurySep 9, 2026Adverse Event Without Identified Device or Use Problem
The patient was revised due to dislocation and cup disassembly on (b)(6) 2026. The implantation date was on (b)(6) 2026. A cup and astem were explanted. A cup, screws and a stm were implanted.
Patient problems: Joint Laxity
MAUDE report 50687053 ↗InjuryJul 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2018. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. A SPACER WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 19644107 ↗InjuryApr 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO SURGICAL CORRECTION (PÉRIPROSTHETIC BONE FRACTURE) ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP AND A STEM WERE EXPLANTED. A CUP AND A STEM WERE IMPLANTED.
Patient problems: Bone Fracture(s)
MAUDE report 19162471 ↗InjuryJun 8, 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 AND SCREWS WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A STEM AND SCREWS WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17084693 ↗InjuryApr 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP AND A STEM WERE EXPLANTED. A CUP AND A STEM WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 16700717 ↗InjuryDec 24, 2021Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED ON (B)(6) 2021 FOR INFECTION, APPROXIMATELY ONE MONTH AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED STEM SIZE 14, CENTERED GLENOSPHERE, POST EXTENSION, 135/145° Ø40+3 CUP, TWO LOCKING SCREW, TWO SCREW AND GLENOID BASEPLATE. THE SURGEON IMPLANTED STEM SIZE 14, CENTERED GLENOSPHERE, POST EXTENSION, Ø40+9CUP, TWO LOCKING SCREW, TWO SCREW AND GLENOID BASEPLATE.
Patient problems: Unspecified Infection
MAUDE report 13083528 ↗InjuryJul 9, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED THE SAME DAY THAN THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE SIZE 14 CEMENTLESS STEM AND REPLACED IT BY A SIZE 12 CEMENTLESS STEM. HE ALSO EXPLANTED THE Ø40/+3 135/145 HUMERAL CUP AND REPLACED IT BY Ø40/+9 135/145 HUMERAL CUP.
Patient problems: Insufficient Information
MAUDE report 12143138 ↗
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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