Humelock II Cemented Reversible Shoulder 103-0809Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 03701037300114), received between Jul 13, 2021 and May 11, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INSTABILITY RESULTING FROM THE REMOVAL OF A GLENOSPHERE ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE AND SCREWS WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE AND SCREWS WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 25134831 ↗
• InjuryJul 1, 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) 2024. A CUP, A GLENOSPHERE AND A METAGLENE WERE EXPLANTED. AN ECCENTRIC TAPER ADAPTER AND AN HELMET HEAD WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 22371712 ↗
• InjuryMay 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 6 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO PATIENT INSTABILITY. 36 MM + 9 STANDARD HUMERAL CUP WAS EXPLANTED AND REPLACED WITH 36 MM + 9 STABILITY HUMERAL CUP AND 9 MM SPACER.

  Patient problems: Joint Laxity

  MAUDE report 19287108 ↗
• InjuryFeb 27, 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) 2023. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 18786892 ↗
• InjuryJan 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED APPROXIMATELY 10 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. PATIENT WAS REVISED FOR AN INFECTION AFTER REPORTING PAIN/SORENESS AROUND THE SHOULDER; THE REVISION SURGERY INCLUDED A WASH OF THE SITE TO PREVENT RE-INFECTION. 36 MM + 9 HUMERAL CUP EXPLANTED AND REPLACED WITH A 36 MM + 6 STABILITY HUMERAL CUP AND 9 MM SPACER.

  Patient problems: Medical device site infection

  MAUDE report 18554453 ↗
• InjuryJan 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) 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 18541967 ↗
• InjuryDec 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY OCCURRED APPROXIMATELY 2 MONTHS AFTER THE PRIMARY SURGERY; PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR TRAUMA REPORTED. PATIENT DISLOCATED. 36 MM + 9 STANDARD HUMERAL CUP WAS EXPLANTED AND REPLACED WITH 36 MM + 6 HUMERAL STABILITY CUP AND 9 MM SPACER.

  Patient problems: Joint Dislocation

  MAUDE report 18310782 ↗
• InjurySep 28, 2023Unstable; Unstable

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

  Patient problems: Subluxation

  MAUDE report 17832289 ↗
• InjuryAug 1, 2023Unstable; Unstable

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

  Patient problems: Subluxation

  MAUDE report 17433074 ↗
• InjuryAug 4, 2022Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT WAS REVISED ON (B)(6) 2019 DUE TO LOOSENING, APPROXIMATELY 973 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP, 1 CENTERED GLENOSPHERE, 1 GLENOID BASEPLATE, 4 LOCKING SCREW. THE SURGEON IMPLANTED 1 OFFSET HEAD AND 1 ECCENTRIC ADAPTER.

  Patient problems: Failure of Implant

  MAUDE report 15162856 ↗
• InjuryApr 5, 2022Device Dislodged or Dislocated

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 1 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP Ø36+9. THE SURGEON IMPLANTED 1 HUMERAL SPACER AND 1 HUMERAL CUP STABILITY Ø36+6.

  Patient problems: Insufficient Information

  MAUDE report 14009924 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR INSTABILITY. APPROXIMATELY 6 MONTHS AFTER THE LAST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP (36/9). THE SURGEON IMPLANTED 1 HUMERAL SPACER (9) AND 1 HUMERAL CUP (36/9).

  Patient problems: Insufficient Information

  MAUDE report 13899750 ↗
• InjuryMar 14, 2022Unstable

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR THE THIRD TIME DUE TO CHRONIC INSTABILITY. DETAILS ON PREVIOUS SHOULDER SURGERIES ARE AS BELOW: 2ND REVISION: (B)(6) 2021 (MDR 3014128390-2021-00045). 1ST REVISION: (B)(6) 2020 (MDR 3014128390-2020-00056). PRIMARY SURGERY: (B)(6) 2019. THE SURGEON EXPLANTED A HUMERAL CUP (36/9) AND IMPLANTED A HUMERAL SPACER (9) AND A HUMERAL CUP (36/6).

  MAUDE report 13763160 ↗
• InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR INFECTION. APPROXIMATLY 21 DAYS AFTER THE FIRST SURGERY. THE SUREGON EXPLANTED 1 HUMERAL CUP Ø36+9. THE SUREGON IMPLANTED 1 STABILTY HUMERAL CUP Ø36+9.

  Patient problems: Unspecified Infection

  MAUDE report 13652793 ↗
• InjuryMar 2, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR DISLOCATION. APPROXIMATELY 107 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP Ø36+9. THE SURGEON IMPLANTED 1 HUMERAL CUP Ø36+6 AND 1 HUMERAL SPACER.

  Patient problems: Insufficient Information

  MAUDE report 13652723 ↗
• InjuryFeb 7, 2022Device Dislodged or Dislocated

  PATIENT WAS REVISED ON (B)(6) 2022 DUE TO A DISLOCATION. APPROXIMATELY 18 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED CORTICAL SCREW, Ø36+9 CUP AND Ø36/10 STEM. THE SURGEON IMPLANTED CORTICAL SCREW, Ø36+6 CUP, Ø36/10 STEM AND HUMERAL SPACER.

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

  MAUDE report 13470573 ↗
• InjuryJan 5, 2022Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED FOR A SECOND TIME ON (B)(6) 2021 AFTER INITIAL REVISION SURGERY ON (B)(6) 2021 AND THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO PATIENT NON-COMPLIANCE. THE PATIENT IS AN ALCOHOLIC AND AGAIN HAD A FALL WHICH REQUIRED A REVISION. THE HUMERAL CUP (36/9) WAS EXPLANTED. A HUMERAL CUP (36/3) AND HUMERAL SPACER (9MM) WAS IMPLANTED.

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

  MAUDE report 13168123 ↗
• InjuryDec 27, 2021Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO AN INFECTION, APPROXIMATELY 7 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED Ø32/08 STEM, 36+9 CUP, TWO CORTICAL SCREW, CENTERED GLENOSPHERE, TWO LOCKING SCREW, ONE STANDARD SCREW AND GLENOID BASEPLATE. THE SURGEON IMPLANTED POST EXTENSION, TWO LOCKING SCREW, EXCENTRED GLENOSPHERE, 36+6 CUP, ONE STANDARD SCREW, GLENOID BASEPLATE AND STEM Ø32/06.

  Patient problems: Unspecified Infection

  MAUDE report 13086836 ↗
• InjuryDec 14, 2021Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED ON (B)(6) 2021 DUE TO INSTABILITY APPROXIMATELY TWO YEARS FOLLOWING PRIMARY SURGERY ON (B)(6) 2019. SURGEON EXPLANTED THE 36/+9 STANDARD HUMERAL CUP, AND THEN IMPLANTED A 36/+6 STANDARD HUMERAL CUP AND A +9MM HUMERAL SPACER.

  Patient problems: Insufficient Information

  MAUDE report 13002128 ↗
• InjuryJul 13, 2021Device Dislodged or Dislocated

  PATIENT REVISED ON (B)(6) 2021 DUE TO DISLOCATION FROM FALLING OUT OF BED, APPROXIMATELY 6 WEEKS AFTER PRIMARY SURGERY. SURGEON EXPLANTED 36/+9 STANDARD HUMERAL CUP AND REPLACED IT WITH A 36/+6 STABILITY HUMERAL CUP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 12159241 ↗