Humelock Cemented Shoulder Prosthesis 106-4300Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 03701037300480), received between Feb 18, 2021 and Dec 21, 2023 — classified as 4 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryDec 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  THE PATIENT WAS REVISED FOR REDUCED MOBILITY ON (B)(6) 2023, RESULTING FROM THE DETERIORATION OF THE ROTATOR CUFF FOLLOWING NON-COMPLIANCE WITH INSTALLATION TECHNIQUES (ASCENSION OF THE STEM NOT LOCKED BY THE OPERATOR).THE IMPLANTATION DATE WAS ON (B)(6) 2023. AN OFFSET HEAD AND A DOUBLE TAPER WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE AND SCREWS WERE IMPLANTED.

  Patient problems: Implant Pain

  MAUDE report 18370729 ↗
• InjuryMay 10, 2023Unstable; Unstable

  THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A HEAD AND A DOUBLE TAPER WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE AND A POST EXTENSION WERE IMPLANTED.

  Patient problems: Subluxation

  MAUDE report 16902582 ↗
• InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO CUFF TEAR. APPROXIMATELY 1 YEARS AND 3 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 ECCENTRIC HEAD, 1 3-4 PEGS GLENOID AND 1 DOUBLE TAPER. THE SURGEON IMPLANTED 1 HUMERAL CUP 135/145° Ø36+3, 1 GELNOID BASEPLATE, 1 ECCENTRIC GLENOSPHERE, 2 LOCKING SCREW AND 2 STANDARD SCREW.

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

  MAUDE report 13994530 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED DUE TO CUFF TEAR ON (B)(6) 2021. APPROXIMATELY 420 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 3-4 PEGS GLENOID (S), 1 OFFSET HEAD (43X17) AND 1 DOUBLE TAPER (0). THE SURGEON IMPLANTED 1 CENTERED GLENOSPHERE (36), 1 GLENOID BASEPLATE (24/3), 1 HUMERAL CUP (36/3), 1 POST EXTENSION (6), 1 LOCKING SCREW (30) AND 3 LOCKING SCREW (20).

  Patient problems: Insufficient Information

  MAUDE report 13899288 ↗
• MalfunctionFeb 18, 2021Material Split, Cut or Torn

  PATIENT REVISED ON (B)(6) 2021, FOLLOWING A DISLOCATION WHICH CAUSED A TEAR IN THE ROTATOR CUFF. SURGEON CONVERTED TOTAL ANANATOMIC TO A REVERSE ; EXPLANTING THE SIZE S 3-4 PEG GLENOID, 43X17 OFFSET COCR HEAD, AND +0MM DOUBLE TAPER ; THEN IMPLANTING 135/145 36/+6 STABILITY CUP, 35MM CENTERED GLENOSPHERE WITH SCREW, 24 MM BASEPLATE WITH CENTRAL SCREW, AND 4 LOCKING SCREWS. THIS WAS INITIALLY REPORTED BY OUR IMPORTER UNDER MDR 3014128390-2021-00001.

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

  MAUDE report 11342777 ↗

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-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
• 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