Humelock II Cemented Reversible Shoulder 314-0703Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03701037301500), received between Feb 18, 2021 and Apr 29, 2026 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryApr 29, 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.

  Patient problems: Joint Dislocation

  MAUDE report 25025241 ↗
• InjuryJun 17, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS REVISED DUE TO DISASSEMBLY OF THE CUP ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE AND AN OFFSET MODULAR SYSTEM WERE EXPLANTED. A CUP, A GLENOSPHERE AND AN OFFSET MODULAR SYSTEM WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 22229455 ↗
• InjuryJan 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Joint Laxity

  MAUDE report 18475845 ↗
• InjuryFeb 9, 2023Unstable; Unstable

  THE PATIENT WAS REVISED DUE TO AN INSTABILITY/DISLOCATION ON (B)(6) 2023. THE FIRST IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND GLENOSPHERE WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 16331613 ↗
• InjuryJun 1, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATLY 4 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 CENTERED GLENOSPHERE 40, 1 HUMERAL CUP 40+3 AND 1 STEM 14. THE SURGEON IMPLANTED 1 HUMERAL CUP, 1 GLENOSPHERE, 1 GLENOID BASEPLATE, 1 POST EXTENSION, 1 STEM, 2 CORTICAL SCREW, 2 STANDARD SCREW AND 1 LOCKING SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 14565142 ↗
• InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATLY 56 DAYS AFTER THE LAST SURGERY AND 70 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP 135/145° Ø40+3, 1 GLENOSPHERE, 2 LOCKING SCREW, 1 GLENOID BASEPLATE AND 2 STANDARD SCREW. THE SURGEON IMPLANTED 1 DOUBLE TAPER AND 1 HELMET HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 13995203 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR INFECTION. APPROXIMATELY 4 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 2 LOCKING SCREW, 2 STANDARD SCREW, 1 POST EXTENSION, 1 GLENOID BASEPLATE, 1 CENTERED GLENOSPERE WITH SCREW, 1 HUMERAL CUP 135/145 Ø40+3 AND 1 HUMÉRIS STEM SIZE 08. THE SURGEON IMPLANTED 1 STANDARD SCREW, 1 POST EXTENSION, 2 LOCKING SCREW, 1 GLENOID BASEPLATE, 1 CENTERED GLENOSPHERE, 1 HUMERAL CUP 135/145 Ø36+3 AND 1 HUMÉRIS STEM SIZE 12.

  Patient problems: Unspecified Infection

  MAUDE report 13899149 ↗
• InjuryMar 3, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR DISLOCATION FOR SECOND TIME ( (B)(6) 2022). THE FIRST SURGERY WAS REALISED ON (B)(6) 2022. THE SURGEON EXPLANTED 1 HUMERAL CUP 135/145° Ø40+3. THE SURGEON IMPLANTED 1 STABILITY CUP Ø40+3.

  Patient problems: Joint Dislocation

  MAUDE report 13657969 ↗
• InjuryMar 2, 2022Device Dislodged or Dislocated

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR DISLOCATION. APPROXIMATLY 1 MONTH AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP 135/145 40+3. THE SURGEON IMPLANTED 1 HUMERAL CUP 135/145 40+6.

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

  MAUDE report 13651827 ↗
• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION ON (B)(6) 2021, ONE MONTHS FOLLOWING THE FIRST SURGERY. THE SURGEON EXPLANTED 40+3 CUP AND IMPLANTED 40+3 CUP.

  Patient problems: Unspecified Infection

  MAUDE report 13087661 ↗
• InjuryDec 23, 2021Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO A DISLOCATION. APPROXIMATELY 5 WEEKS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 135/145° Ø40+3 HUMERAL CUP AND IMPLANTED Ø40+9 STABILITY CUP.

  Patient problems: Joint Dislocation

  MAUDE report 13072257 ↗
• InjuryOct 22, 2021Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED DUE TO SURGEON'S CHOICE ON (B)(6) 2021. APPROXYMATELY, 2 MONTHS AFTER THE FIRTS SURGERY. CUP Ø135/145 40+3 WAS EXPLANTED AND CUP Ø135/145 36+3 WAS IMPLANTED.

  Patient problems: Insufficient Information

  MAUDE report 12680962 ↗
• InjuryFeb 19, 2021Unstable

  REVISION FOR INSTABILITY. SURGEON EXPLANTED CENTERED GLENOSPHERE AND REPLACED BY AN EXENTRIC GLENOSPHERE.

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

  MAUDE report 11347877 ↗
• InjuryFeb 18, 2021Device Dislodged or Dislocated

  REVISION FOR DISLOCATION . THE PATIENT DISLOCATED HIS OWN SHOULDER BY LIFTING A WEIGHTY OBJECT DURING HIS CONVALESCENCE. THE SURGEON REPLACED THE CUP WITH A STABILITY CUP.

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

  MAUDE report 11342695 ↗