Humelock II Cementless Shoulder System 311-0208Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03701037301029), received between Mar 28, 2023 and Jan 23, 2026 — classified as 4 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 18, 2026.

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON 20. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE AND A STEM WERE EXPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 24162373 ↗
• InjuryJan 15, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE EXPLANTED WITHOUT REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 24078662 ↗
• InjuryDec 16, 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 GLENOSPHERE AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 23814983 ↗
• InjuryMar 28, 2023Microbial Contamination of Device; Microbial Contamination of Device

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

  Patient problems: Medical device site infection

  MAUDE report 16628543 ↗