Humelock Cemented Shoulder Prosthesis 106-3914Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03701037300381), received between Apr 9, 2021 and Apr 15, 2024 — classified as 3 injuries.

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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 15, 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 HEX SCREW, AN OFFSET MODULAR SYSTEM, A HEAD AND A DOUBLE TAPER WERE EXPLANTED. AN HEX SCREW, AN OFFSET MODULAR SYSTEM, A HEAD, SMARTAPS AND A DOUBLE TAPER WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 19103593 ↗
• InjuryMar 29, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO UNKNOWN REASON. APPROXIMATELY 1 DAY AFTER THE LAST SURGERY. THE SURGEON EXPLANTED 1 DOUBLE TAPER AND 1 CENTERED HEAD 39. THE SURGEON IMPLANTED 1 ECCENTRIC HEAD 43 AND 1 CENTERED SPACER Ø43+3MM.

  Patient problems: Insufficient Information

  MAUDE report 13937813 ↗
• InjuryApr 9, 2021Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO A FAILURE OF THE ROTATOR CUFF APPROXIMATELY 5 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE EASYTECH ANATOMICAL SYSTEM, THE REVISION SURGERY IS USING THE HUMELOCK REVERSED SYSTEM. THE SURGEON EXPLANTED THE +0 DOUBLE TAPER, THE XS ANATOMICAL GLENOID, THE Ø39 CENTERED HEAD AND THE Ø34 ANCHOR BASE. HE IMPLANTED A CEMENTED METAPHYSIS Ø32 STEM, A Ø24 BASEPLATE, A Ø36 CENTERED GLENOSPHERE, Ø36 HUMERAL CUP, A 10MM POST EXTENSION AND ASSOCIATED SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 11641750 ↗

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