Humelock Cemented Shoulder Prosthesis 106-4316Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03701037300404), received between May 27, 2021 and May 21, 2026 — classified as 6 injuries.

The most frequently reported specific device problem is “Output Problem” (1 report).

2 other recalls cover devices cleared under the same FDA submission (K111097); they may or may not involve this specific model.

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 21, 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 HEAD AND A DOUBLE TAPER WERE EXPLANTED. A HEAD AND A DOUBLE TAPER WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 25242124 ↗
• InjuryMay 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A PAIN ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2024.A CENTRED HEAD AND A DOUBLE TAPER WERE EXPLANTED. A RESURFACING GLENOIDE, A DOUBLE TAPER, A CENTRED HEAD WERE IMPLANTED.

  Patient problems: Implant Pain

  MAUDE report 22068334 ↗
• InjuryJan 5, 2022Output Problem

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO DISMANTLING, APPROXIMATELY 3 WEEKS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED CENTERED HEAD (43/16) AND IMPLANTED CENTERED HEAD 43/16.

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

  MAUDE report 13168711 ↗
• InjurySep 10, 2021Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED APPROXIMATELY A MONTH AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE EASYTECH ANATOMICAL SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE 43X16MM CENTERED HEAD, THE +0MM DOUBLE TAPER AND THE ANATOMICAL GLENOID. THEN, HE CONVERTED ANATOMICAL CONFIGURATION TO A REVERSE CONFIGURATION BY IMPLANTING A Ø24 BASEPLATE, A +10MM POST EXTENSION, A Ø36 ECCENTRIC GLENOSPHERE, A 135/145 Ø36/+3 HUMERAL CUP AND ASSOCIATED SCREWS.

  Patient problems: Joint Dislocation

  MAUDE report 12452019 ↗
• InjuryJun 24, 2021Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY TO CONVERT THE HEMI IN FULL ANATOMICAL PROSTHESIS DUE TO PATIENT HEALTH STATE. THE SURGEON EXPLANTED THE DOUBLE TAPER AND THE 43*16 CENTERED HEAD. THEN HE IMPLANTED A NEW DOUBLE TAPER, A NEW 43*16 CENTERED HEAD AND A SIZE S ANATOMICAL GLENOID.

  Patient problems: Insufficient Information

  MAUDE report 12056167 ↗
• InjuryMay 27, 2021Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION APPROXIMATELY 2 YEARS AFTER THE PRIMARY SURGERY. THE PRIMAR SURGERY USED THE EASYTECH ANATOMICAL SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE 43 X 16 CENTERED HEAD AND THE +0MM DOUBLE TAPER. IT WAS REPLACED BY A REVERSED CONFIGURATION. THE SURGEON IMPLANTED A Ø24 BASEPLATE, A Ø36 CENTERED GLENOSPHERE, A Ø36/+3 135/145 HUMERAL CUP AND ASSOCIATED SCREWS.

  Patient problems: Joint Dislocation

  MAUDE report 11892151 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K111097. One submission often covers many models, so check the product and lot details in each record.

• Z-2468-2018 · Jun 4, 2018 · Terminated
  Fx SOLUTIONS CENTERED HEAD CoCr 50x19, REF 106-5019 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and ot
• Z-2469-2018 · Jun 4, 2018 · Terminated
  Fx SOLUTIONS OFFSET HEAD CoCr 50x20, REF 106-5000 Product Usage: Device is designed to produce and deliver proton beam for the treatment of patients with localized tumors and othe