Humelock Reversed ShoulderRecalls & reported problems across all models

We found 13 models of Humelock Reversed Shoulder by Fx Solutions in the FDA's device registry (GUDID). Together they are named in 32 adverse event reports in the FDA's MAUDE database, received between Feb 19, 2021 and Jul 8, 2026 — classified as 31 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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

Most reported Humelock Reversed Shoulder problems

Humelock Reversed Shoulder models

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

• Humelock Reversed Shoulder 317-3208

  Shoulder Prosthesis, Reverse Configuration
  7 reports
• Humelock Reversed Shoulder 317-3614

  Shoulder Prosthesis, Reverse Configuration
  6 reports
• Humelock Reversed Shoulder 317-4014

  Shoulder Prosthesis, Reverse Configuration
  6 reports
• Humelock Reversed Shoulder 103-0007

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  2 reports
• Humelock Reversed Shoulder 313-3206

  Shoulder Prosthesis, Reverse Configuration
  2 reports
• Humelock Reversed Shoulder 317-4012

  Shoulder Prosthesis, Reverse Configuration
  2 reports
• Humelock Reversed Shoulder 105-0000

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• Humelock Reversed Shoulder 106-5400

  Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented
  1 report
• Humelock Reversed Shoulder 313-4010

  Shoulder Prosthesis, Reverse Configuration
  1 report
• Humelock Reversed Shoulder 317-3210

  Shoulder Prosthesis, Reverse Configuration
  1 report
• Humelock Reversed Shoulder 317-3610

  Shoulder Prosthesis, Reverse Configuration
  1 report
• Humelock Reversed Shoulder 317-4016

  Shoulder Prosthesis, Reverse Configuration
  1 report
• Humelock Reversed Shoulder 903-0102

  Orthopedic Manual Surgical Instrument
  1 report

Recent Humelock Reversed Shoulder adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS, A HUMERAL SPACER AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, A POST EXTENSION, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 25746946 ↗
• InjuryMay 28, 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 CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE EXPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 25317094 ↗
• InjuryMar 13, 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 CUP, A GLENOSPHERE, A GLENOID BASEPLATE AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, A POST EXTENSION, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 24597477 ↗
• InjuryFeb 6, 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 CUP, A GLENOSPHERE, A GLENOID BASEPLATE, A POST EXTENSION, SCREWS AND A STEM WERE EXPLANTED WITHOUT REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 24276539 ↗
• InjuryJan 12, 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 CUP, A GLENOSPHERE, A GLENOID BSAE PLATE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BSAE PLATE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 24034017 ↗
• InjuryOct 17, 2025Adverse 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). 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, HUMERAL SPACER AND A STEM WERE EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 23320845 ↗
• InjuryAug 5, 2025Adverse 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) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025.A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. IMPLANT REMOVAL WITHOUT REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 22714096 ↗
• InjuryJul 24, 2025Adverse 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) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 22586126 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 20 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 40/12 SYSTEM STEM AND 40 MM + 6 HUMERAL STABILITY CUP WERE EXPLANTED. THESE PARTS WERE REPLACED WITH A 40/12 V135 120MM STEM, 40 MM + 3 HUMERAL STANDARD CUP, AND A 9 MM SPACER.

  Patient problems: Joint Dislocation

  MAUDE report 22107656 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS REPORT IS A FOLLOW UP TO PER 24-602 / MDR 3014128390-2024-00046. ANY DISCREPANCIES BETWEEN THIS CORRECTED ACCOUNT AND THE PRIOR REPORT ARE ATTRIBUTED TO THE PATIENT'S EXTREME RELUCTANCE TO SHARE INFORMATION. REVISION OCCURRED ON (B)(6) 2024, APPROXIMATELY 5 YEARS AFTER THE PRIOR REVISION SURGERY WHICH OCCURRED ON (B)(6) 2019; THIS SURGERY WAS A POLY SWAP FOR INFECTION AND CONCERNS OF ASPIRATION. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2017. NO FALL OR OTHER TRAUMA REPORTED. REVISION WAS A TOTAL EXPLANTATION OF ALL FX PRODUCT, FOLLOWING A LENGTHY REGIMEN OF EFFUSIONS TO TREAT ATYPICAL METALLOSIS, DETAILED BELOW. 40/14 SYSTEM STEM, 24 MM CEMENTLESS GLENOID BASEPLATE, 40 MM CENTERED GLENOSPHERE, 40 MM + 6 HUMERAL STANDARD CUP, AND 9 MM HUMERAL SPACER EXPLANTED. THESE PARTS WERE REPLACED WITH AN ANTIBIOTIC SPACER. PATIENT WAS DRAINED OF FLUID AT THE IMPLANT SITE ONCE EVERY 2-4 WEEKS FOR "SEVERAL YEARS", POTENTIALLY AS FAR BACK AS THE PRIMARY SURGERY, ALTHOUGH THE 2019 REVISION IS THE 1ST RECORD OF METALLOSIS FOR THE PATIENT FROM AVAILABLE DATA. ON (B)(6) 2024, THE PATIENT UNDERWENT ANOTHER SURGERY TO REPLACE THE ANTIBIOTIC SPACER; THERE WAS NO FX PRODUCT IN THE PATIENT AT THIS TIME

  Patient problems: Metal Related Pathology

  MAUDE report 20240609 ↗
• MalfunctionMay 14, 2024Contamination /Decontamination Problem; Contamination /Decontamination Problem

  WHEN CHECKING THE INSTRUMENTATION INTO THE HOSPITAL FOR A CASE ON (B)(6) 2024, THE STERILIZATION OFFICER PULLED TWO T HANDLES FROM THE KIT FOR CONTAMINATION. THE STERILIZATION OFFICER BELIEVED THE CONTAMINANT TO BE BLOOD OR BIOBURDEN. BASED ON A REVIEW OF PROVIDED PHOTOS, THE CONTAMINANT IS LIKELY RUST. REGARDLESS, THE PARTS WERE CLEANED TO THE HOSPITAL'S STANDARDS BEFORE CHECK IN WAS FINALIZED. NO SURGICAL DELAY OCCURRED AS THE CASE THE INSTRUMENTATION WAS FOR HAD ALREADY BEEN RESCHEDULED FOR UNRELATED REASONS. CAPA-2024-0027 HAS BEEN OPENED TO ADDRESS THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19315591 ↗
• InjuryJan 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 9 MONTHS AFTER PRIMARY SURGERY, WHICH OCCURRED ON (B)(6)2022. REVISION OCCURRED DUE TO INFECTION. THE REVISION WAS A TOTAL EXPLANT OF THE SYSTEM, INCLUDING THE STEM, BASEPLATE, 36 MM CENTERED GLENOSPHERE, 36 MM + 9 STANDARD HUMERAL CUP, AND 4 SCREWS. THIS SYSTEM WAS REPLACED WITH A COMPETITOR'S ANTI-BIOTIC SPACER TO TREAT THE INFECTION. FIRST NOTIFICATION OF THIS REVISION WAS GIVEN BY THE REPRESENTATIVE ON (B)(6) 2023, IN PURSUANCE OF INFORMATION REGARDING A SUBSEQUENT REVISION FOR THE SAME PATIENT, INVOLVING AN EXPLANT OF THE ANTI-BIOTIC SPACER AND A REPLACEMENT OF AN FX SYSTEM.

  Patient problems: Medical device site infection

  MAUDE report 18495830 ↗
• InjuryNov 21, 2023Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REVISION WAS PERFORMED APPROXIMATELY 1 MONTH AFTER THE PRIMARY SURGERY; PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA NOTED. PATIENT PRESENTED WITH A LOOSENED STEM WITHIN THE HUMERAL CANAL. 36X14 STEM, 40 MM +3 STABILITY HUMERAL CUP, AND 9 MM SPACER EXPLANTED. THESE PARTS WERE REPLACED WITH A 40X14 STEM, 40 MM + 3 STABILITY HUMERAL CUP, 9 MM SPACER, A 34 MM CORTICAL SCREW, AND A 28 MM CORTICAL SCREW. THE PRIMARY SURGERY WAS TREATMENT FOR A FRACTURE. CONTRARY TO THE SURGICAL TECHNIQUE FOR THE PRIMARY SURGERY, THE SURGEON DID NOT INCLUDE ANY DISTAL SCREWS, WHICH ALLOWED THE STEM TO LOOSEN. SURGEON STATED THAT ALL FUTURE PROXIMAL HUMERAL FRACTURES WILL BE TREATED WITH DISTAL SCREWS.

  Patient problems: Inadequate Osseointegration

  MAUDE report 18187434 ↗
• InjuryNov 7, 2023Migration; Migration

  REVISION WAS PERFORMED APPROXIMATELY 3 MONTHS AFTER PRIMARY SURGERY FOR BASEPLATE LOOSENING AND DISLOCATION. NO FALL OR OTHER TRAUMA NOTED. REVISION WAS A CONVERSION TO HEMI CONFIGURATION AS A RESULT OF DISLOCATION. PRIMARY SURGERY OCCURRED (B)(6) 2023. 32 MM CENTERED GLENOSPHERE, 32 MM + 3 STANDARD HUMERAL CUP, GLENOID BASEPLATE, AND 32/8 REVERSE STEM EXPLANTED. REPLACED WITH 36/12 LONG STEM, 48 MM OFFSET HEAD, AND 24/10 ECCENTRIC TAPER ADAPTER.

  Patient problems: Joint Dislocation

  MAUDE report 18088291 ↗
• InjuryOct 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 2 MONTHS AFTER PREVIOUS REVISION FOR POTENTIAL INFECTION AT IMPLANT SITE. OFFSET HUMERAL HEAD, OFFSET 24 MM TAPER ADAPTER, AND 20 MM SCREW EXPLANTED. REPLACED WITH 24 MM TAPER ADAPTER AND CENTERED HUMERAL HEAD.

  Patient problems: Medical device site infection

  MAUDE report 17976075 ↗

Other Fx Solutions products

• Humelock II Cemented Reversible Shoulder23 models · 406 reports
• TiN Coated Glenosphere5 models · 27 reports · 1 recall
• Humelock Cemented Shoulder Prosthesis7 models · 22 reports · 1 recall
• Humeral Cup Stability15 models · 65 reports
• Humeris Shoulder9 models · 35 reports
• Humelock II Cementless Shoulder System5 models · 26 reports
• Easytech Anatomical Shoulder System4 models · 24 reports
• Humelock II Cemented Shoulder System9 models · 20 reports