Humelock II Cementless Shoulder SystemRecalls & reported problems across all models

We found 5 models of Humelock II Cementless Shoulder System by Fx Solutions in the FDA's device registry (GUDID). Together they are named in 26 adverse event reports in the FDA's MAUDE database, received between Feb 15, 2021 and Jun 29, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Fracture” (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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Humelock II Cementless Shoulder System problems

Humelock II Cementless Shoulder System models

5 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Humelock II Cementless Shoulder System 311-0212

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  15 reports
• Humelock II Cementless Shoulder System 311-0210

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  5 reports
• Humelock II Cementless Shoulder System 311-0208

  Plate, Fixation, Bone
  4 reports
• Humelock II Cementless Shoulder System 107-4524

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• Humelock II Cementless Shoulder System 107-4526

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report

Recent Humelock II Cementless Shoulder System adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJun 29, 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) 2026. 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 25651778 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2026. A CUP, A GLENOSPHERE, A SCREW AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, SCREW AND A STEM WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 24711478 ↗
• InjuryMar 17, 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.

  Patient problems: Medical device site infection

  MAUDE report 24617082 ↗
• InjuryMar 2, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO DISLOCATION AND INFECTION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2026. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, A POST EXTENSION, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS, A REVERSED ADAPTE, A POST EXTENSION AND A STEM WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 24482567 ↗
• 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 ↗
• InjuryMay 6, 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) 2024. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE EXPLANTED. REMOVAL WITHOUT IMPLANT REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 21966965 ↗
• InjuryDec 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A DISLOCATION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP AND A STEM WERE EXPLANTED. A CUP, A SCREW AND A STEM WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 20925429 ↗
• InjuryNov 19, 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) 2024. REMOVAL WITHOUT REPLACEMENT OF IMPLANTS.

  Patient problems: Medical device site infection

  MAUDE report 20722694 ↗
• InjuryJun 26, 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) 2024. A CUP, A GLENOSPHERE, A METAGLENE, AN OFFSET MODULAR SYSTEM AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 19614739 ↗
• InjuryJun 26, 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) 2024. AN HELMET HEAD, A DOUBLE TAPER, SCREWS AND A STEM WERE EXPLANTED. AN HELMET HEAD, A DOUBLE TAPER, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 19613061 ↗
• InjuryJun 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A LOOSENING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. AN HELMET HEAD AND A DOUBLE TAPER WERE IMPLANTED.

  Patient problems: Inadequate Osseointegration

  MAUDE report 19565173 ↗
• InjuryJun 13, 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 GLENOSPHERE, A METAGLENE , AN OFFSET MODULAR SYSTEM AND A STEM WERE EXPLANTED. A DOUBLE TAPER AND AN HELMET HEAD WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 19526287 ↗
• InjuryMay 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PAIN ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A SCREW WAS EXPLANTED.

  Patient problems: Implant Pain

  MAUDE report 19403986 ↗

Other Fx Solutions products

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