Humeris Shoulder 316-0012Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03701037301579), received between Jul 13, 2021 and Nov 24, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Break” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryNov 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTION AND INSTABILITY ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 23630134 ↗
• InjuryJul 18, 2025Adverse 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) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP AND A STEM WERE EXPLANTED. A CUP, A HUMERAL SPACER AND A STEM WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 22544177 ↗
• InjuryJul 6, 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 AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 17265812 ↗
• InjuryJan 20, 2023Unstable; Unstable

  THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2022. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP, A GLENOSPHERE AND A STEM WERE EXPLANTED. NO IMPLANT WAS IMPLANTED.

  Patient problems: Subluxation

  MAUDE report 16214312 ↗
• InjuryFeb 3, 2022Break

  THE PATIENT WAS OPERATED ON (B)(6) 2021 AND DURING THE OPERATION THE SCREW HEADS WERE BROKEN AND THE OPERATION LASTED 2 HOURS. THIS EVENT IS THE RESULT OF A RECOVERY FOR INFECTION. THIS REVISION FOR INFECTION TOOK PLACE 6 YEARS AFTER THE FIRST INSTALLATION. THE SURGEON EXPLANTED HUMERIS STEM SIZE 12, TWO LOCKING SCREW, TWO STANDARD SCREW, CENTERED GLENOSPHERE, 135/145° Ø40+3 CUP AND GLENOID BASE PLATE. THE SURGEON IMPLANTED HUMERIS STEM SIZE 10, TWO LOCKING SCREW, TWO STANDARD SCREW, CENTERED GLENOSPHERE, 135/145° Ø40+3 CUP AND GLENOID BASE PLATE.

  Patient problems: Unspecified Infection

  MAUDE report 13442022 ↗
• InjuryJan 12, 2022Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO A ALLERGY, THE SAME DAY OF THE FIRST SURGERY. THE SURGEON EXPLANTED HUMERIS STEM TA6V SIZE 12, CENTERED GLENOSPHERE AND 135/145 ° Ø36+3 CUP. THE SURGEON IMPLANTED HUMERIS STEM TA6V SIZE 12, CENTERED GLENOSPHERE COCR TIN AND 135/145 ° Ø36+3 CUP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 13235858 ↗
• InjuryJul 13, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO POSTOP FRACTURE (DUE TO A PATIENT'S FALL) THAT OCCURED APPROXIMATELY 28 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISON SURGERY, THE SURGEON EXPLANTED THE SIZE 12 CEMENTLESS STEM AND REPLACED IT BY A LONG SIZE 8 CEMENTED STEM. HE ALSO EXPLANTED THE Ø36/+3 135/145 HUMERAL CUP AND REPLACED IT BY THE SAME PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 12159222 ↗