Humelock II Cemented Shoulder SystemRecalls & reported problems across all models
Fx Solutions · 9 models in the FDA device registry
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 20
- Deaths reported
- 0
- Injuries reported
- 18
- Recalls
- 0
We found 9 models of Humelock II Cemented Shoulder System by Fx Solutions in the FDA's device registry (GUDID). Together they are named in 20 adverse event reports in the FDA's MAUDE database, received between Feb 23, 2021 and Sep 23, 2026 — classified as 18 injuries, 2 malfunctions.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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
Reports received per month, all models
Most reported Humelock II Cemented Shoulder System problems
Device problems
- Appropriate Device Problem Term/Code Not Available6
- Adverse Event Without Identified Device or Use Problem4
- Device Dislodged or Dislocated2
- Tear, Rip or Hole in Device Packaging2
- Break1
- Failure to Osseointegrate1
- Loose or Intermittent Connection1
- Manufacturing, Packaging or Shipping Problem1
Patient problems
- Joint Laxity6
- No Clinical Signs, Symptoms or Conditions4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available2
- Failure of Implant2
- Insufficient Information2
- Medical device site infection2
- Pain2
- Unspecified Infection1
Humelock II Cemented Shoulder System models
9 models, most reported first. Each model has its own page with its reports, recalls and device details.
- Humelock II Cemented Shoulder System 112-0000Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented6 reports
- Humelock II Cemented Shoulder System 106-4800Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented4 reports
- Humelock II Cemented Shoulder System 105-0002Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented2 reports
- Humelock II Cemented Shoulder System 106-4100Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2 reports
- Humelock II Cemented Shoulder System 311-0310Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented2 reports
- Humelock II Cemented Shoulder System 105-0004Prosthesis, Shoulder, Non-Constrained, Metal/Polymer Cemented1 report
- Humelock II Cemented Shoulder System 106-4818Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 report
- Humelock II Cemented Shoulder System 311-0508Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented1 report
- Humelock II Cemented Shoulder System 451-0019Orthopedic Manual Surgical Instrument1 report
Recent Humelock II Cemented Shoulder System adverse event reports
The 15 most recent reports across all models, in the reporter's own words as published by the FDA.
InjurySep 23, 2026Manufacturing, Packaging or Shipping Problem
An incident occurred during a prosthesis implantation procedure in Argentina: upon opening the implant box, it was found to be empty containing no implant, labels, or instructions for use. There were no consequences for the patient's health, other than a one-hour extension of the operating time.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 50869011 ↗MalfunctionMay 16, 2025Tear, Rip or Hole in Device Packaging; Tear, Rip or Hole in Device Packaging
IN A CASE WITH THE SURGEON ON (B)(6) 2025, A 48X18 CENTERED HEAD WAS OPENED DURING SURGERY AND THE TRAY WAS SEEN TO BE CRACKED IN A MANNER THAT BREACHES THE STERILE BARRIER. THE TRAY HAS CRACKED IN THE CORNER OPPOSITE PEELING CORNER, RESULTING IN CHIPPING OF THE SEALING LIP. THE TYVEK BARRIER WAS PEELED BACK APPROXIMATELY 1 INCH AS A RESULT OF THE DAMAGE. THE COMPONENT ITSELF, AND THE PLASTIC WRAPPED SEAL, APPEAR TO NOT HAVE BEEN COMPROMISED. NO SURGICAL DELAY WAS NOTED. CAPA-2024-0039 HAS BEEN OPENED TO ADDRESS THIS ISSUE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22039760 ↗InjuryMar 3, 2025Break; Break
THREADED K-WIRE BREAKAGE DURING INTERVENTION, THE CAUSE IS SECONDARY TO IMPROPER USE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21503328 ↗InjuryJan 27, 2025Adverse 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) 2014.
Patient problems: Joint Laxity
MAUDE report 21240827 ↗InjuryOct 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INSTABILITY ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED.
Patient problems: Joint Laxity
MAUDE report 20532415 ↗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 ↗InjuryDec 18, 2023Adverse 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) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A DOUBLE TAPER AND AN OFFSET HEAD WERE EXPLANTED. A DOUBLE TAPER AND AN OFFSET HEAD WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 18344001 ↗InjuryMay 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2020. A CUP, A GLENOSPHERE, A METAGLENE,A STEM AND SCREWS WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, A STEM, SMARTLOOP AND SCREWS WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 16928946 ↗InjuryMar 2, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2022. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A DOUBLE TAPER +0MM AND AN OFFSET HEAD 50X20 WERE EXPLANTED. A DOUBLE TAPER +0MM AND AN OFFSET HEAD 50X20 WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 16468214 ↗InjuryNov 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated
THE PATIENT WAS REVISED (B)(6) 2022 AFTER THE PRIMARY SURGERY ON 2018 DUE TO LOOSENING. A HEAD AND A DOUBLE CONE WERE EXPLANTED. A GLENOSPHERE, 3 SCREWS, A METAGLENE, A CUP AND A TAPER WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 15786694 ↗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 ↗InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO BREAK. APPROXIMATELY 5 YEARS AND 7 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 2 PEGS GLENOID, 1 DOUBLE TAPER, 1 ANCHOR BASE AND 1 HEAD 43X16. THE SURGEON IMPLANTED 1 HUMERAL CUP 135/145° Ø36+3, 1 ECCENTRIC GLENOSPHERE, 2 STANDARD SCREW, 1 GLENOID BASEPLATE AND 1 LOCKING SCREW.
Patient problems: Insufficient Information
MAUDE report 13993971 ↗InjuryApr 4, 2022Unstable
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INSTABILITY. APPROXIMATELY 5 MONTHS AFTER THE LAST SURGERY. THE SURGEON EXPLANTED 1 DOUBLE TAPER (0), 1 2 PEGS GLENOID (L) AND 1 OFFSET HEAD (50X20). THE SURGEON IMPLANTED 1 GLENOID BASEPLATE (24), 1 CENTRAL SCREW (12), 2 STANDARD SCREW (25), 2 LOCKING SCREW (20, 15), 1 CENTERED GLENOSPHERE (40) AND 1 HUMERAL CUP (40/3).
Patient problems: Joint Laxity
MAUDE report 13993200 ↗InjuryJan 6, 2022Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED ON (B)(6) 2021 DUE TO PATIENT STATE, APPROXIMATELY 3 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED DOUBLE TAPER AND BILBOQUET. THE SURGEON IMPLANTED 135/145 Ø36+3 CUP, GLENOID BASEPLATE, CENTERED GLENOSPHERE, TWO STANDARD SCREW (L25MM AND L20MM) AND TWO LOCKING SCREW (L30MM AND L25MM).
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13174945 ↗InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available
PATIENT WAS REVISIT ON (B)(6) 2021 FOR INFECTION. APPROXIMATELY 15 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED DOUBLE TAPER TA6V AND CENTERED HEAD CRO 46*17. THE SURGEON IMPLANTED CENTERED HEAD CRO 46-17 AND DOUBLE TAPER TA6V.
Patient problems: Unspecified Infection
MAUDE report 12873593 ↗
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 Reversed Shoulder13 models · 32 reports
- Humelock II Cementless Shoulder System5 models · 26 reports
- Easytech Anatomical Shoulder System4 models · 24 reports
Sources and updates
- Models: FDA GUDID, file dated Oct 13, 2026. Models are grouped by the brand name the manufacturer registered.
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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