Humelock Reversed Shoulder 317-3614Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03701037303757), received between Jan 28, 2022 and May 28, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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.

• InjuryMay 28, 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, SCREWS AND A STEM WERE EXPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 25317094 ↗
• InjuryJan 12, 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 BSAE PLATE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BSAE PLATE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 24034017 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 9 MONTHS AFTER PRIMARY SURGERY, WHICH OCCURRED ON (B)(6)2022. REVISION OCCURRED DUE TO INFECTION. THE REVISION WAS A TOTAL EXPLANT OF THE SYSTEM, INCLUDING THE STEM, BASEPLATE, 36 MM CENTERED GLENOSPHERE, 36 MM + 9 STANDARD HUMERAL CUP, AND 4 SCREWS. THIS SYSTEM WAS REPLACED WITH A COMPETITOR'S ANTI-BIOTIC SPACER TO TREAT THE INFECTION. FIRST NOTIFICATION OF THIS REVISION WAS GIVEN BY THE REPRESENTATIVE ON (B)(6) 2023, IN PURSUANCE OF INFORMATION REGARDING A SUBSEQUENT REVISION FOR THE SAME PATIENT, INVOLVING AN EXPLANT OF THE ANTI-BIOTIC SPACER AND A REPLACEMENT OF AN FX SYSTEM.

  Patient problems: Medical device site infection

  MAUDE report 18495830 ↗
• InjuryNov 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REVISION WAS PERFORMED APPROXIMATELY 1 MONTH AFTER THE PRIMARY SURGERY; PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA NOTED. PATIENT PRESENTED WITH A LOOSENED STEM WITHIN THE HUMERAL CANAL. 36X14 STEM, 40 MM +3 STABILITY HUMERAL CUP, AND 9 MM SPACER EXPLANTED. THESE PARTS WERE REPLACED WITH A 40X14 STEM, 40 MM + 3 STABILITY HUMERAL CUP, 9 MM SPACER, A 34 MM CORTICAL SCREW, AND A 28 MM CORTICAL SCREW. THE PRIMARY SURGERY WAS TREATMENT FOR A FRACTURE. CONTRARY TO THE SURGICAL TECHNIQUE FOR THE PRIMARY SURGERY, THE SURGEON DID NOT INCLUDE ANY DISTAL SCREWS, WHICH ALLOWED THE STEM TO LOOSEN. SURGEON STATED THAT ALL FUTURE PROXIMAL HUMERAL FRACTURES WILL BE TREATED WITH DISTAL SCREWS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18187434 ↗
• InjuryJun 21, 2022Unstable; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO CHRONIC INSTABILITY LEADING TO DISLOCATION FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2020. A HUMERAL CUP (36/6), HUMELOCK REVERSED STEM (14), TWO STANDARD SCREWS (20), STANDARD SCREW (25), STANDARD SCREW (35), GLENOSPHERE (36) AND GLENOID BASEPLATE (24) WERE EXPLANTED. A HUMERAL CUP (36/6), HUMERAL SPACER (9), POST EXTENSION (6), THREE STANDARD SCREWS (30), STANDARD SCREW (35), GLENOSPHERE (36) AND GLENOID BASEPLATE (24) WERE IMPLANTED.

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

  MAUDE report 14757310 ↗
• InjuryJan 28, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT DEVELOPED SEROMA WHICH LED TO A REVISION SURGERY ON (B)(6) 2021, APPROXIMATELY A WEEK AFTER THE PRIMARY SURGERY ON (B)(6) 2021 TO AVOID INFECTION. ONLY THE HUMERAL CUP (40/9) WAS REPLACED WITH A NEW HUMERAL CUP (40/9).

  Patient problems: Seroma

  MAUDE report 13384811 ↗