Humelock Reversed Shoulder 317-4014Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03701037303788), received between Jan 25, 2022 and Jul 8, 2026 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 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) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS, A HUMERAL SPACER AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, A POST EXTENSION, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 25746946 ↗
• InjuryFeb 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) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, A POST EXTENSION, SCREWS AND A STEM WERE EXPLANTED WITHOUT REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 24276539 ↗
• InjuryOct 17, 2025Adverse 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). 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, HUMERAL SPACER AND A STEM WERE EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 23320845 ↗
• InjuryJul 24, 2025Adverse 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) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 22586126 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS A FOLLOW UP TO PER 24-602 / MDR 3014128390-2024-00046. ANY DISCREPANCIES BETWEEN THIS CORRECTED ACCOUNT AND THE PRIOR REPORT ARE ATTRIBUTED TO THE PATIENT'S EXTREME RELUCTANCE TO SHARE INFORMATION. REVISION OCCURRED ON (B)(6) 2024, APPROXIMATELY 5 YEARS AFTER THE PRIOR REVISION SURGERY WHICH OCCURRED ON (B)(6) 2019; THIS SURGERY WAS A POLY SWAP FOR INFECTION AND CONCERNS OF ASPIRATION. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2017. NO FALL OR OTHER TRAUMA REPORTED. REVISION WAS A TOTAL EXPLANTATION OF ALL FX PRODUCT, FOLLOWING A LENGTHY REGIMEN OF EFFUSIONS TO TREAT ATYPICAL METALLOSIS, DETAILED BELOW. 40/14 SYSTEM STEM, 24 MM CEMENTLESS GLENOID BASEPLATE, 40 MM CENTERED GLENOSPHERE, 40 MM + 6 HUMERAL STANDARD CUP, AND 9 MM HUMERAL SPACER EXPLANTED. THESE PARTS WERE REPLACED WITH AN ANTIBIOTIC SPACER. PATIENT WAS DRAINED OF FLUID AT THE IMPLANT SITE ONCE EVERY 2-4 WEEKS FOR "SEVERAL YEARS", POTENTIALLY AS FAR BACK AS THE PRIMARY SURGERY, ALTHOUGH THE 2019 REVISION IS THE 1ST RECORD OF METALLOSIS FOR THE PATIENT FROM AVAILABLE DATA. ON (B)(6) 2024, THE PATIENT UNDERWENT ANOTHER SURGERY TO REPLACE THE ANTIBIOTIC SPACER; THERE WAS NO FX PRODUCT IN THE PATIENT AT THIS TIME

  Patient problems: Metal Related Pathology

  MAUDE report 20240609 ↗
• InjuryJan 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD UNDERGONE A PRIMARY SURGERY ON (B)(6) 2021 AND A REVISION SURGERY ON (B)(6) 2021 DUE TO INFECTION. ALL THE FX PRODUCTS IMPLANTED DURING THE PRIMARY SURGERY ON (B)(6) 2021 WERE EXPLANTED AND AN ANTIBIOTIC SPACER FROM ANOTHER MANUFACTURER WAS IMPLANTED. LATER, THE PATIENT WAS REVISED FOR THE SECOND TIME ON (B)(6) 2021, DURING WHICH THE ANTIBIOTIC SPACER WAS EXPLANTED AND THE FX PRODUCTS WERE IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 13347705 ↗