Humelock Cemented Shoulder ProsthesisRecalls & reported problems across all models

We found 7 models of Humelock Cemented Shoulder Prosthesis by Fx Solutions in the FDA's device registry (GUDID). Together they are named in 22 adverse event reports in the FDA's MAUDE database, received between Feb 18, 2021 and May 21, 2026 — classified as 21 injuries, 1 malfunction.

The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (1 report).

1 FDA recall record name at least one of these models by its device identifier.

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Humelock Cemented Shoulder Prosthesis recalls

FDA recall records that name at least one of these models by its device identifier, newest first. Each recall usually covers specific models or lots, so check the details.

1. Jun 4, 2018Terminated

   Breach in the external blister of certain lots of Humelock Offset Head 50 X 20 and Centered Head 50 X 19.

   Z-2468-2018 · Root cause: Package design/selection · Recall details · FDA record ↗

Most reported Humelock Cemented Shoulder Prosthesis problems

Humelock Cemented Shoulder Prosthesis models

7 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Humelock Cemented Shoulder Prosthesis 106-5019

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 recall1 report
• Humelock Cemented Shoulder Prosthesis 106-4316

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  6 reports
• Humelock Cemented Shoulder Prosthesis 106-4300

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  5 reports
• Humelock Cemented Shoulder Prosthesis 106-3914

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  3 reports
• Humelock Cemented Shoulder Prosthesis 106-4600

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  3 reports
• Humelock Cemented Shoulder Prosthesis 106-4617

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  2 reports
• Humelock Cemented Shoulder Prosthesis 106-3900

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  2 reports

Recent Humelock Cemented Shoulder Prosthesis adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryApr 4, 2022Adverse Event Without Identified Device or Use Problem

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

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

  MAUDE report 13994503 ↗
• InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATELY 1 YEAR AND 9 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 2PEGS GLENOID, 1 DOUBLE TAPER, 1 ANCHOR BASE AND 1 CENTERED HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 13993395 ↗
• 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 ↗
• 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 ↗
• InjuryFeb 2, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR CUFF TEAR. APPROXIMATELY 1 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 STEM, 1 DOUBLE TAPER AND 1 CENTERED HEAD. THE SURGEON IMPLANTED 1 GLENOID BASEPLATE, 1 STEM Ø36/10 , 1 ECCENTRED GLENOSPHERE, 2 LOCKING SCREW, 2 STANDARD SCREW, 1 HUMERAL CUP Ø40+6 AND 1 CORTICAL SCREW.

  Patient problems: Insufficient Information

  MAUDE report 13421310 ↗
• 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 ↗
• InjuryOct 8, 2021Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO ROTATOR CUFF TEAR. THE PRIMARY SURGERY USED THE EASYTECH ANATOMIC SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE +0MM DOUBLE TAPER AND THE 50X19 CENTERED HEAD. THEN, HE IMPLANTED A Ø36/+6 135/145 HUMERAL CUP, A 6MM POST EXTENSION, A Ø24 BASEPLATE, A Ø36 ECCENTRIC GLENOSPHERE AND ASSOCIATED SCREWS.

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12598069 ↗
• 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 ↗

Other Fx Solutions products

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