Humelock II Cemented Shoulder System 106-4800Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 03701037300503), received between Jul 19, 2021 and Oct 18, 2024 — classified as 3 injuries, 1 malfunction.

The most frequently reported specific device problem is “Failure to Osseointegrate” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 18, 2024Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging

  DURING SURGERY, 2 OF 48X19 OFFSET HEAD WAS OPENED AND IT WAS SEEN THAT THE SIDE WALL OF THE PLASTIC TRAY WAS DAMAGED, BREAKING THE PRIMARY STERILE BARRIER. THE WHITE OUTER BOX WAS UNDAMAGED AND DID NOT SHOW ANY SIGNS OF THE CONTAINED DEFECT. APPROXIMATELY 10 MINUTES OF SURGICAL DELAY NOTED. CAPA: 2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20484868 ↗
• InjuryApr 8, 2022Patient Device Interaction Problem

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR THE SECOND TIME DUE TO INSTABILITY. DETAILS ON PREVIOUS SHOULDER SURGERIES ARE AS BELOW: 1ST REVISION: (B)(6) 2021 (MDR 3014128390-2021-00053). PRIMARY SURGERY: (B)(6) 2021. THE SURGEON EXPLANTED A OFFSET HEAD (50X20), 2 PEGS GLENOID AND DOUBLE TAPER. A GLENOID BASEPLATE (24), CENTERED GLENOPSHERE (40), HUMERAL CUP (40/3), CENTRAL SCREW (12), STANDARD SCREWS (2 OF 25 MM EACH) AND LOCKING SCREWS (20 MM AND 15 MM).

  Patient problems: Joint Laxity

  MAUDE report 14056600 ↗
• InjuryOct 22, 2021Failure to Osseointegrate; Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED ON (B)(6) 2021 DUE TO ROTATOR CUFF FAILURE, APPROXIMATELY 9 MONTHS FOLLOWING PRIMARY SURGERY. THE SURGEON EXPLANTED 3-4 PE GLENOID SIZE S, SIZE 48 +5 MM CENTERED SPACER AND 48*9 OFFSET COCR HEAD. THE SURGEON IMPLANTED Ø135/145 36/+3 STANDARD HUMERAL CUP, 36MM CENTERED GLENOSPHERE WITH SCREW, 24MM GLENOID BASEPLATE AND +6MM POST EXTENSION.

  Patient problems: Failure of Implant

  MAUDE report 12678959 ↗
• InjuryJul 19, 2021Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED ON (B)(6) 2021 DUE TO CONTINUED PAIN FOLLOWING PRIMARY SURGERY ON (B)(6) 2020. SURGEON CONVERTED ANATOMIC TO A REVERSE, EXPLANTING ALL COMPONENTS EXCEPT STEM (3-4 PEG GLENOID SIZE L, 48X19 OFFSET COCR HEAD, +0MM DOUBLE TAPER) AND THEN IMPLANTING 24MM CEMENTLESS GLENOID BASEPLATE, +6MM POST EXTENSION, 40MM CENTERED GLENOSPHERE WITH SCREW, 135/145 40/+3 STANDARD HUMERAL CUP, AND 4 SCREWS.

  Patient problems: Failure of Implant; Pain

  MAUDE report 12188099 ↗