Humelock Cemented Shoulder Prosthesis 106-4600Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03701037300497), received between Apr 9, 2021 and May 27, 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.

• InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO A LOOSENING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2020. AN OFFSET HEAD, A CENTRED SPACER AND A 2 PEGS GLENOID WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE AND SCREWS WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 19400479 ↗
• InjurySep 10, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED ON (B)(6) 2021 DUE TO LIMITED RANGE OF MOTION APPROXIMATELY 2 YEARS FOLLOWING PRIMARY SURGERY. SURGEON CONVERTED ANATOMIC CONFIGURATION TO A REVERSE CONFIGURATION, EXPLANTING ALL COMPONENTS EXCEPT THE HUMERAL STEM (3-4 PEG GLENOID SIZE M, +0MM DOUBLE TAPER, 46X18 OFFSET COCR HEAD), AND THEN IMPLANTING COMPONENTS REQUIRED FOR A REVERSE (24MM GLENOID BASEPLATE, 36MM CENTERED GLENOSPHERE WITH SCREW, 135/145 36/+3 STANDARD HUMERAL CUP, 4 SCREWS).

  Patient problems: Loss of Range of Motion

  MAUDE report 12452023 ↗
• InjuryApr 9, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY DUE TO A HEAVY RUPTURE OF THE SUPRASPINATUS OCCURED ON (B)(6) 2021. DOUBLE TAPER, Ø46 ECCENTRIC HEAD, Ø36 CAGE AND ASSOCIATED SCREWS WERE REMOVED AND REPLACED BY Ø24 BASEPLATE, Ø36 ECCENTRIC GLENOSPHERE, 135/145° STANDARD HUMERAL CUP AND ASSOCIATED SCREWS.

  Patient problems: Rupture

  MAUDE report 11641735 ↗

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