Humelock II Cemented Shoulder System 112-0000Recalls & reported problems
Fx Solutions · DOUBLE TAPER TA6V +0 mm 0° · Class 2 · Implant
All models of Humelock II Cemented Shoulder System (9)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 6
- Deaths reported
- 0
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 03701037300732), received between Nov 25, 2021 and Sep 23, 2026 — classified as 6 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Appropriate Device Problem Term/Code Not Available1
- Device Dislodged or Dislocated1
- Manufacturing, Packaging or Shipping Problem1
- Microbial Contamination of Device1
Patient problems
- Medical device site infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Laxity1
- No Clinical Signs, Symptoms or Conditions1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, 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 ↗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 ↗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 ↗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 Prosthesis, Shoulder, Hemi-, Humeral, Metallic Uncemented devices
- DJO SURGICAL 509-02-032Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED364 reports
- DELTA XTEND 130790036Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED171 reports
- DELTA XTEND 130770018Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED159 reports
- TRIGEN 71118200Smith & Nephew, Inc. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED123 reports
- DJO SURGICAL 509-02-432Encore Medical, L.P. · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED119 reports
- DELTA XTEND 130738206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED116 reports
- COMPREHENSIVE SHOULDER SYSTEM 113633Biomet Orthopedics, LLC · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED2 recalls4 reports
- DELTA XTEND 130742206Depuy (Ireland) · PROSTHESIS, SHOULDER, HEMI-, HUMERAL, METALLIC UNCEMENTED99 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
How reports and recalls are matched · Editorial policy · Report an error on this page