Humelock II Cemented Reversible Shoulder 104-0806Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03701037300138), received between Mar 25, 2022 and Jul 6, 2026 — classified as 15 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryJul 6, 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 25715681 ↗
• InjuryMar 2, 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) 2020. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 24480827 ↗
• InjuryApr 4, 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 WAS EXPLANTED. A CUP WAS IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 21772637 ↗
• InjurySep 6, 2024Migration; Migration

  THE PATIENT WAS REVISED DUE TO A DISMANTLING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2021. A CUP, A GLENOSPHERE, A METAGLENE AND SCREWS WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A POST EXTENSION AND SCREWS WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 20154883 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 13 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION WAS A POLY SWAP DUE TO INFECTION. 40 MM + 6 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH AN IDENTICAL PART.

  Patient problems: Medical device site infection

  MAUDE report 19626943 ↗
• InjuryMay 3, 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 AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 19236298 ↗
• InjuryApr 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 7 WEEKS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. THE SYSTEM IS A HYBRID OF FX V135 STEM AND CUP ON THE HUMERAL SIDE AND A COMPETITOR'S PRODUCTS ON THE GLENOID SIDE. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 40 MM + 6 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH 40 MM + 9 STABILITY HUMERAL CUP.

  Patient problems: Joint Dislocation

  MAUDE report 19053586 ↗
• InjuryNov 9, 2023Adverse 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) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2019. A CUP WAS EXPLANTED. A CUP AND A HUMERAL SPACER WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 18101133 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 3 WEEKS AFTER PRIMARY SURGERY FOR DISLOCATION. PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. 40 MM + 6 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH A 40 MM + 3 STABILITY HUMERAL CUP AND 9 MM SPACER. POST REVISION, IT WAS DISCOVERED THAT THE PATIENT HAD AN UNDERLYING INFECTION.

  Patient problems: Joint Dislocation

  MAUDE report 18066118 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DISLOCATION OCCURRED APPROXIMATELY TWO MONTHS AFTER INITIAL IMPLANTATION DATE. NO FALL OR TRAUMA EVIDENT. STANDARD 40 MM + 6 HUMERAL CUP AND 9 MM HUMERAL SPACER EXPLANTED. REPLACEMENT WITH 40 MM + 9 HUMERAL CUP AND 9 MM HUMERAL SPACER.

  Patient problems: Joint Dislocation

  MAUDE report 17959785 ↗
• InjuryJul 11, 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 WAS EXPLANTED. A CUP WAS IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 17297110 ↗
• InjuryJun 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) 2022. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 17077137 ↗
• InjuryMay 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(4) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 16982247 ↗
• InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISMANTLING. APPROXIMATELY 9 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 CENTERED GLENOSPHERE AND 1 HUMERAL CUP Ø40+6. THE SURGEON IMPLANTED 1 CENTERED GLENOSPHERE AND 1 HUMERAL CUP Ø40+6.

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

  MAUDE report 13994894 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR CUFF TEAR. APPROXIMATELY 35 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP Ø40+6. THE SURGEON IMPLANTED 1 HUMERAL CUP 40+9.

  Patient problems: Insufficient Information

  MAUDE report 13901030 ↗