Humelock II Cementless Shoulder System 311-0212Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 03701037301067), received between Feb 15, 2021 and Mar 30, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Unstable” (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.

• 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 ↗
• 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 ↗
• 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 ↗
• InjuryNov 20, 2023Adverse 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, A GLENOSPHERE, A METAGLENE, A SMARTAPE, SMARTLOOPS, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A SMARTAPE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 18168360 ↗
• InjuryApr 13, 2023Unstable; Unstable

  THE PATIENT WAS REVISED DUE TO SHOULDER INSTABILITY ON (B)(6) 2022. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP AND A STEM WERE EXPLANTED. A CUP, A SCREW AND A STEM WERE IMPLANTED.

  Patient problems: Damage to Ligament(s)

  MAUDE report 16731549 ↗
• InjuryJan 12, 2023Microbial Contamination of Device; Microbial Contamination of Device

  THE PATIENT WAS REVISED DUE TO A REVISION FOR INFECTION ON (B)(6) 2022. THE IMPLANTATION DATE WAS ON (B)(6) 2022 (DATE UNKNOWN). A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. NO IMPLANT WAS IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 16146789 ↗
• InjurySep 9, 2022Patient Device Interaction Problem; Patient Device Interaction Problem

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION, APPROXIMATELY 351 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 STEM, 1 GLENOSPHERE, 1 METAGLENE, 1 CUP, 6 SCREWS. THE SURGEON IMPLANTED 1 STEM, 1 GLENOSPHERE, 1 CUP, 4 SCREWS.

  Patient problems: Medical device site infection

  MAUDE report 15389160 ↗
• InjuryDec 24, 2021Output Problem; Material Split, Cut or Torn

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO CUFF TEAR, APPROXIMATELY 5 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED STEM TA6V SIZE 12, DOUBLE TAPER, CENTERED HEAD, TWO CORTICAL SCREW, OFFSET MODULAR SYSTEM AND HEX SCREW. THE SURGEON IMPLANTED STEM TA6V SIZE 10, HUMERAL CUP 36+6, GLENOID BASEPLATE, TWO LOCKING SCREW AND SCREW.

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

  MAUDE report 13083522 ↗
• InjuryAug 5, 2021Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY. THE REASON OF THE REVISION IS UNKNOWN. THE PRIMARY SURGERY USED THE HUMELOCK II REVERSED SYSTEM. THE SURGEON EXPLANTED ALL THE COMPONENTS OF THE REVERSE TOTAL SHOULDER ARTHROPLASTY. NO COMPONENTS WERE IMPLANTED. HE EXPLANTED THE Ø40 ECCENTRIC GLENOSPHERE, THE Ø40/+9 STANDARD HUMERAL CUP, THE Ø24 BASEPLATE, THE SIZE 12 CEMENTLESS STEM AND ASSOCIATED SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 12279195 ↗
• InjuryMay 10, 2021Fracture; Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO POSTOP FRACTURE (DUE TO TRAUMA) THAT OCCURED APPROXIMATELY 2 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMAR SURGERY USED THE ANATOMICAL HUMELOCK II SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED ALL THE COMPONENTS : THE +0 DOUBLE TAPER, THE SIZE 12 CEMENTLESS STEM, THE 39X15 OFFSET HEAD, A CORTICAL SCREW AND SMARTLOOPS.

  Patient problems: Insufficient Information

  MAUDE report 11796989 ↗
• InjuryMar 18, 2021Insufficient Device Problem Information

  REVISION FOR A FRACTURE FOLLOWING AN ACCIDENT. SURGEON EXPLANTED THE STEM 12 AND THE CUP 135/145 AND REPLACE BY STEM 10 AND SAME CUP.

  Patient problems: Bone Fracture(s)

  MAUDE report 11515348 ↗
• InjuryFeb 15, 2021Unstable

  ANATOMICAL HUMELOCK 2 + GLENOID 2 PLOTS PLACED ON TRAUMA ON (B)(6) 2020. PROSTHESIS PLACED A FEW WEEKS AFTER THE FRACTURE BECAUSE OF MULTIPLE TRAUMA PATIENTS WITH OTHER LESIONS REQUIRING MORE URGENT TREATMENT.. DUE TO INSTABILITY AND DISLOCATION, THE SURGEON REMOVAL OF ALL IMPLANTS ON (B)(6) 2021 IN PLACE AND REPLACE WITH A HUMELOCK REVERSED.

  Patient problems: Joint Dislocation

  MAUDE report 11326784 ↗