Humelock II Cemented Reversible Shoulder 105-4010Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03701037300305), received between May 11, 2021 and Jun 15, 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.

• InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED ON (B)(6) 2026. ALL REQUIRED INFORMATION WAS RECEIVED ON 09-JUN-2026. REVISION SURGERY OCCURRED APPROXIMATELY 134 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA WAS REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø40MM AND FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3 WAS EXPLANTED DUE TO DISLOCATION AND REPLACED WITH HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø36MM, FX V135 HUMERAL SPACER TA6V +9MM AND FX V135 HUMERALCUP 135/145° STABILITY PE/TA6V Ø36 +3. FX V135® HUMELOCK STEM TA6V Ø36/12 L. 120MM CEMENTLESS TI/HA WAS NOT REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 25511107 ↗
• InjuryMay 7, 2026Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 77 DAYS AFTER THE PRIMARY SURGERY ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3 AND HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø40MM WAS EXPLANTED DUE TO DISLOCATION. THESE PARTS WERE REPLACED WITH FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +9. FX V135® HUMELOCK STEM TA6V Ø36/12 L. 120MM CEMENTLESS TI/HA WAS NOT REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 25113536 ↗
• InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 12 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 40 MM CENTERED GLENOSPHERE AND A 40 MM + 3 STANDARD HUMERAL CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM ECCENTRIC GLENOSPHERE AND A 40 MM + 3 STABILITY 135/145 HUMERAL CUP.

  Patient problems: Joint Dislocation

  MAUDE report 23324714 ↗
• InjuryJun 18, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS REVISED DUE TO DISMANTLING OF THE GLÉNOSPHÈRE ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. THE SURGEON'S HYPOTHESIS IS AN INITIAL IMPACTION DEFECT DUE TO POOR INTRAOPERATIVE EXPOSURE.A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 22273586 ↗
• InjuryFeb 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 7 WEEKS AFTER THE PRIOR REVISION, WHICH OCCURRED ON (B)(6) 2024. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION. 40 MM CENTERED GLENOSPHERE, AND 40 MM + 9 HUMERAL STABILITY CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE, 40 MM + 9 HUMERAL STABILITY CUP, AND 9 MM SPACER.

  Patient problems: Medical device site infection

  MAUDE report 21327250 ↗
• InjuryJan 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP, A GLENOSPHERE WERE EXPLANTED. A CUP, A GLENOSPHERE WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 18561636 ↗
• InjuryOct 13, 2023Unstable; Unstable

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

  Patient problems: Subluxation

  MAUDE report 17929060 ↗
• InjuryMar 2, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 28 DAYS AFTER THE LAST SURGERY. THE SURGEON EXPLANTED 1 CENTERED GLENOSPHERE WITH SCREW Ø40, 1 STEM Ø32/10, 1 HUMERAL CUP 135/145° STABILITY Ø36+3, 2 CENTERED GLENOSPHERE WITH SCREW AND 2 CORTICAL SCREWS. THE SURGEON IMPLANTED 1 HUMERAL CUP STABILITY Ø40+9, 1 ECCENTRIC GLENOSPHERE WITH SCREW, 1 STEM Ø32/10, 2 CORTICAL SCREWS AND 1 HUMERAL SPACER.

  Patient problems: Joint Dislocation

  MAUDE report 13651646 ↗
• InjuryFeb 1, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED FOR INFECTION ON (B)(6) 2021. APPROXIMATELY 2 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMELOCK STEM, 1 CENTERED GLENOSPHERE WITH SCREW, 1 HUMERAL CUP Ø40+9, 1 GLENOID BASEPLATE, 1 POST EXTENSION, 1 STANDARD SCREW L25MM, 1 STANDARD SCREW L35MM AND 2 LOCKING SCREW. THE SURGEON IMPLANTED 1 POST EXTENSION, 1 GLENOID BASEPLATE, 2 LOCKING SCREW, 2 STANDARD SCREW, 1 ECCENTRIC GLENOSPHERE WITH SCREW, 1 HUMELOCK STEM, 2 CORTICAL SCREW AND 1 HUMERAL CUP 135/145° Ø40+9.

  Patient problems: Unspecified Infection

  MAUDE report 13415776 ↗
• InjuryJan 28, 2022Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO INFECTION, APPROXIMATELY 8 WEEKS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 40+3 HUMERAL CUP AND CENTERED GLENOSPHERE. THE SURGEON IMPLANTED CENTERED GLENOSPHERE AND 40+3 SYMMETRIC CUP.

  Patient problems: Unspecified Infection

  MAUDE report 13385335 ↗
• InjuryDec 24, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO INFECTION, APPROXIMATELY 1 MONTH AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED CENTERED GLENOSPHERE AND HUMERAL CUP Ø40+3. THE SURGEON IMPLANTED HUMERAL CUP Ø40+6 AND CENTERED GLENOSPHERE.

  Patient problems: Unspecified Infection

  MAUDE report 13083679 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED ON (B)(6) 2021 DUE TO PAIN, APPROXIMATELY 14 MONTHS FOLLOWING PRIMARY SURGERY. SURGEON EXPLANTED 40MM CENTERED GLENOSPHERE WITH SCREW AND 135/145 40/+3 STANDARD HUMERAL CUP, PERFORMED A WASHOUT, AND THEN IMPLANTED A NEW 40MM CENTERED GLENOSPHERE WITH SCREW, 40/+3 STANDARD HUMERAL CUP, AND 135/145 REVERSED ADAPTER FOR AN EXTRA +9MM OF SPACING.

  Patient problems: Pain

  MAUDE report 12452024 ↗
• InjurySep 1, 2021Output Problem

  THE EVENT WAS A REVISION SURGERY DUE TO THE GLENOSPHERE DISMANTLING THAT OCCURED APPROXIMATELY A MONTH AFTER PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø40 CENTERED GLENOSPHERE AND THE Ø40/+3 135/145 HUMERAL CUP. THEN, HE IMPLANTED A Ø36 ECCENTRIC GLENOSPHERE AND A Ø36/+3 135/145 HUMERAL CUP.

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

  MAUDE report 12405631 ↗
• InjuryMay 11, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED FOR SECOND TIME ON (B)(6) 2021 DUE TO GLENOSPHERE DISASSOCIATION APPROXIMATELY 1 YEAR AFTER PRIMARY SURGERY. FIRST REVISION PREVIOUSLY REPORTED. SURGEON EXPLANTED THE 40MM CENTERED GLENOSPHERE WITH SCREW, 40/+6 STANDARD HUMERAL CUP, AND 135/145 REVERSED ADAPTER. HE THEN IMPLANTED A NEW 40MM CENTERED GLENOSPHERE WITH SCREW, 40/+6 STANDARD HUMERAL CUP, AND 135/145 REVERSED ADAPTER.

  Patient problems: Joint Dislocation

  MAUDE report 11804456 ↗