Humelock II Cemented Reversible Shoulder 103-0806Recalls & reported problems
Fx Solutions · HUMERAL CUP STANDARD PE/TA6V Ø36/+6 · Class 2 · Implant
All models of Humelock II Cemented Reversible Shoulder (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This FX Solutions Humelock II shoulder cup is used in reverse-configuration shoulder replacement. The 38 reports mostly describe the shoulder joint dislocating or coming apart, infections at the implant site, and loosening with broken screws, leading patients to have revision surgery to remove or swap the cup. There are 38 injuries and no deaths. No recalls name this device. Reports fell from 8 in the earlier 12 months to 2 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 38
- Deaths reported
- 0
- Injuries reported
- 38
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 38 adverse event reports that list this exact device (DI 03701037300107), received between Feb 18, 2021 and Jul 13, 2026 — classified as 38 injuries.
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, 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 Problem22
- Appropriate Device Problem Term/Code Not Available8
- Device Dislodged or Dislocated2
- Microbial Contamination of Device2
- Unstable2
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
- Unexpected Therapeutic Results1
Patient problems
- Joint Dislocation13
- Insufficient Information8
- Medical device site infection8
- Joint Laxity3
- Unspecified Infection3
- Failure of Implant1
- Implant Pain1
- No Clinical Signs, Symptoms or Conditions1
Recent adverse event reports
The 25 most recent of 38 reports, in the reporter's own words as published by the FDA.
InjuryJul 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) 2026. A CUP AND A GLENOSPHERE WERE IMPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 25792337 ↗InjuryDec 15, 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 AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 23802800 ↗InjuryJul 21, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP WAS EXPLANTED. A CUP AND A HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 22553747 ↗InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WILL BE REVISED DUE TO DISLOCATION ON (B)(6) 2025. THE IMPLANTATION DATE UNKNOWN. A CUP WAS EXPLANTED. A CUP AND A HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 22209564 ↗InjuryJun 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 7 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED. THIS WAS REPLACED BY A 36 MM + 3 HUMERAL STABILITY CUP AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 22160836 ↗InjuryMay 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 21967779 ↗InjuryMar 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WILL BE REVISED DUE TO DISLOCATION ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 21502179 ↗InjuryFeb 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO A PROSTHETIC LOOSENING WITH SCREW BREAKAGE ON (B)(6)2025.NO QUESTIONING OF THE EQUIPMENT BY THE SURGEON.THE IMPLANTATION DATE WAS ON (B)(6) 2024, REVISED FOR A FIRST TIME ON (B)(6) 2024.A CUP, A GLÉNOSPHÈRE, A MÉTAGLÈNE AND A POST EXTENSION WERE EXPLANTED.A CUP, A GLÉNOSPHÈRE, A MÉTAGLÈNE AND A POST EXTENSION WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 21396669 ↗InjuryNov 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 6 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH A 36 MM + 3 STANDARD HUMERAL CUP AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 20713990 ↗InjuryNov 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 3 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH A 36 MM + 3 STABILITY CUP AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 20646051 ↗InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 20 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION WAS A POLY SWAP DUE TO DISLOCATION OF UNKNOWN CAUSE. 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH 36 MM + 6 STABILITY HUMERAL CUP AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 20418349 ↗InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2024. THE IMPLANTATION DATE UNKNOWN. A CUP WAS EXPLANTED. A CUP AND A HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 20414812 ↗InjurySep 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 20222571 ↗InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 10 WEEKS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH AN IDENTICAL PART.
Patient problems: Medical device site infection
MAUDE report 19953313 ↗InjuryJul 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP, A GLENOSPHERE AND A HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 19739438 ↗InjuryJul 1, 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) 2024. A CUP WAS EXPLANTED. A CUP AND A REVERSED ADAPTER WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 19644101 ↗InjuryApr 29, 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)2023. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, A POST EXTENSION CEMENTELESS AND A STEM WERE EXPLANTED.
Patient problems: Medical device site infection
MAUDE report 19199847 ↗InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO CORECTION (EVACUATION OF A HEMATOMA) ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Implant Pain
MAUDE report 18612374 ↗InjuryJan 19, 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) 2023. A CUP AND A GLENOSPHERE WAS EXPLANTED. A CUP AND A GLENOSPHERE WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 18541198 ↗InjuryDec 5, 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 (B)(6) 2023. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS AND AN EASYTECH ANCHOR BASE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 18264617 ↗InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION ON 04TH OCTOBER 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP, A GLENOSPHERE AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE AND A STEM WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 17948371 ↗InjuryOct 16, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
DISLOCATION OF SHOULDER APPROX. 2 MONTHS AFTER INITIAL IMPLANTATION. NO FALL OR TRAUMA REPORTED. STANDARD HUMERAL CUP 36 MM + 6 SWAPPED WITH STABILITY HUMERAL CUP 36 MM + 3 AND SPACER + 9 MM.
Patient problems: Joint Dislocation
MAUDE report 17944791 ↗InjuryAug 1, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17433415 ↗InjuryMay 29, 2023Microbial Contamination of Device; Microbial Contamination of Device
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2018. A CUP, A GLENOSPHERE WERE EXPLANTED. A CUP, A GLENOSPHERE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17016430 ↗InjuryApr 13, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP, A GLENOSPHERE, A HUMERAL SPACER AND A CEMENTELESS GLENOID WERE EXPLANTED. A CUP, A GLENOSPHERE, A HUMERAL SPACER AND A CEMENTELESS GLENOID WERE IMPLANTED.
Patient problems: Subluxation
MAUDE report 16731648 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
- DJO SURGICAL 508-36-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration508 reports
- DJO SURGICAL 508-32-101Encore Medical, L.P. · shoulder prosthesis, reverse configuration433 reports
- DJO SURGICAL 508-32-103Encore Medical, L.P. · shoulder prosthesis, reverse configuration421 reports
- DJO SURGICAL 509-00-036Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall259 reports
- DJO SURGICAL 508-32-104Encore Medical, L.P. · shoulder prosthesis, reverse configuration1 recall203 reports
- DJO SURGICAL 509-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration233 reports
- DELTA XTEND 130760000Depuy (Ireland) · shoulder prosthesis, reverse configuration223 reports
- DJO SURGICAL 508-00-032Encore Medical, L.P. · shoulder prosthesis, reverse configuration122 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.
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