Humeris Shoulder 316-0010Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03701037301555), received between Apr 30, 2021 and May 12, 2025 — classified as 9 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.

Most reported problems

Recent adverse event reports

The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjuryMay 12, 2025Adverse 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) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A MÉTAGLÈNE, A GLÉNOSPHÈRE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A MÉTAGLÈNE, A GLÉNOSPHÈRE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 22002843 ↗
• InjuryJul 28, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE PATIENT WILL BE REVISED DUE TO AN INFECTION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM MAY BE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM COULD BE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 17412705 ↗
• InjuryJul 6, 2023Unstable; Unstable

  THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6)2023. THE IMPLANTATION DATE WAS ON (B)(6)2022. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, A POST EXTENSION AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, A POST EXTENSION AND A STEM WERE IMPLANTED.

  Patient problems: Subluxation

  MAUDE report 17265115 ↗
• InjuryMar 2, 2023Unstable; Unstable

  THE PATIENT WAS REVISED DUE TO AN INSTABILITY ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 16468216 ↗
• InjurySep 1, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE EVENT WAS A REVISION SURGERY DUE TO LOOSENING THAT OCCURED APPROXIMATELY A MONTH AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE SIZE 10 CEMENTLESS STEM, THE Ø36/+3 135/145 HUMERAL STEM, THE Ø24 BASEPLATE, THE Ø36 CENTERED GLENOSPHERE AND ASSOCIATED SCREWS. THEN, HE IMPLANTED A SIZE 8 CEMENTLESS STEM, A Ø36/+3 135/145 HUMERAL CUP, A Ø24 BASEPLATE, A Ø36 CENTERED GLENOSPHERE AND ASSOCIATED SCREWS.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12405821 ↗
• InjurySep 1, 2021Device Dislodged or Dislocated

  THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED APPROXIMATELY 2 WEEKS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE SIZE 10 CEMENTLESS STEM, THE Ø36 CENTRED GLENOSPHERE AND THE Ø36/+3 135/145 HUMERAL CUP. THEN, HE IMPLANTED A SIZE 12 CEMENTLESS STEM, A Ø40 ECCENTRIC GLENOSPHERE AND A Ø40/+9 135/145 HUMERAL CUP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12405674 ↗
• InjurySep 1, 2021Device Dislodged or Dislocated

  THE EVENT IS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED APPROXIMATELY 2 WEEKS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE SIZE 10 CEMENTLESS STEM, THE 36/+9 135/145 HUMERAL CUP AND THE 36 CENTERED GLENOSPHERE. THEN HE IMPLANTED A SIZE 12 CEMENTLESS STEM, A 40/+9 135/145 HUMERAL CUP AND A 40 ECCENTRIC GLENOSPHERE.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12405594 ↗
• InjuryJul 13, 2021Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO INFECTION THAT OCCURED APPROXIMATELY 2 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. THE SURGEON EXPLANTED THE Ø36 CENTERED GLENOSPHERE, THE Ø24 BASEPLATE, THE Ø36/+3 135/145 HUMERAL CUP, THE SIZE 10 CEMENTLESS STEM AND ASSOCIATED SCREWS. THEN HE IMPLANTED A NEW GLENOSPHERE, A NEW BASEPLATE, A NEW HUMERAL CUP AND A NEW STEM (SAME NEW PRODUCTS/SAME SIZE). HE ALSO IMPLANTED A 10MM POST EXTENSION AND ASSOCIATED SCREWS.

  Patient problems: Unspecified Infection

  MAUDE report 12159272 ↗
• InjuryApr 30, 2021Adverse Event Without Identified Device or Use Problem

  THIS EVENT WAS A REVISION SURGERY DUE TO DISLOCATION APPROXIMATIVELY 14 DAYS AFTER PRIMARY SURGERY. DISLOCATION DUE TO A FALL OF THE PATIENT. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. THE SURGEON EXPLANTED THE Ø40/+3 STANDARD HUMERAL CUP AND REPLACED IT BY THE SAME PRODUCT. HE ALSO EXPLANTED THE SIZE 10 CEMENTLESS HUMERIS STEM AND REPLACED IT BY A SIZE 12 CEMENTLESS HUMERIS STEM.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 11751478 ↗