Humelock II Cemented Reversible Shoulder 104-0803Recalls & reported problems
Fx Solutions · HUMERAL CUP STANDARD PE/TA6V Ø40/+3 · Class 2 · Implant
All models of Humelock II Cemented Reversible Shoulder (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 14
- Deaths reported
- 0
- Injuries reported
- 14
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 03701037300121), received between Feb 24, 2021 and Apr 27, 2026 — classified as 14 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
- Appropriate Device Problem Term/Code Not Available6
- Adverse Event Without Identified Device or Use Problem5
- Device Dislodged or Dislocated1
- Microbial Contamination of Device1
- Output Problem1
- Patient-Device Incompatibility1
Patient problems
- Joint Dislocation5
- Unspecified Infection5
- Failure of Implant2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Arthritis1
- Bacterial Infection1
- Medical device site infection1
Recent adverse event reports
The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.
InjuryApr 27, 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 STANDARD CUP WAS EXPLANTED. A CUP STABILITY WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 24995953 ↗InjurySep 6, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 16 WEEKS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO A DISLOCATION OF UNKNOWN CAUSE. 40 MM + 3 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH A 40 MM + 9 STANDARD HUMERAL CUP.
Patient problems: Joint Dislocation
MAUDE report 20161411 ↗InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 3 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO A DISLOCATION OF UNKNOWN CAUSE. 40 MM + 3 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH 40 MM + 9 STABILITY HUMERAL CUP.
Patient problems: Joint Dislocation
MAUDE report 20049412 ↗InjuryApr 5, 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) 2022. A CUP WERE EXPLANTED. A CUP WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 16680209 ↗InjuryAug 4, 2022Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. THE SURGEON EXPLANTED 1 STEM Ø36/14, 1 HUMERAL CUP, 1 CENTERED GLENOSPHERE, 1 WHITE SMARTLOOP, 1 LOCKING SCREW L35, 1 GLENOID BASEPLATE Ø24, 1 STANDARD SCREW L35, 1 STANDARD SCREW L25, 1 LOCKING SCREW L40 AND 1 BLUE SMARTAPE. THE SURGEON IMPLANTED 1 STEM Ø36/08, 1 ECCENTRIC TAPER ADAPTER AND 1 HELMET HEAD Ø51.
Patient problems: Unspecified Infection
MAUDE report 15162786 ↗InjuryJun 1, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATELY 2 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERL CUP 36+3, 1 GLENOID BASEPLATE, 1 CENTERED GLENOSPHERE 40, 1 LOCKING SCREW 25, 1 LOCKING SCREW 35 AND 2 STANDARD SCREW 15. THE SURGEON IMPLANTED 1 SMARTLOOP WHITE USP 5, 1 GLENOID BASEPLATE 24, 2 STANDARD SCREW 15, 1 LOCKING SCREW 35, 1 LOCKING SCREW 25, 1 CENTERED GLENOSPHERE 40, 1 HUMERAL CUP 40+3 AND 2 CORTICAL SCREW 26.
Patient problems: Unspecified Infection
MAUDE report 14563931 ↗InjuryMar 2, 2022Output Problem
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISMANTLING. APPROXIMATELY 22 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 GLENOID BASEPLATE 24, 1 POST EXTENSION +6, 3 LOCKING SCREWS, 1 STANDARD SCREW, 1 CENTERED GLENOSPHERE 40 AND 1 HUMERAL CUP 40+3. THE SURGEON IMPLANTED 1 GLENOID BASEPLATE 24, 1 POSTE EXTENSION 10, 2 LOCKING SCREWS 40 AND 35, 2 STANDARD SCREWS 40 AND 30, 1 CENTERED GLENOSPHERE 36 AND 1 HUMERAL CUP 36+3.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13652187 ↗InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available
PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATELY 45 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED Ø40+3 CUP AND IMPLANTED Ø40+3 CUP.
Patient problems: Unspecified Infection
MAUDE report 13469505 ↗InjuryJan 5, 2022Patient-Device Incompatibility
PATIENT WAS REVISED ON (B)(6) 2021 DUE TO A INFECTION. APPROXIMATELY 10 MONTH AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED STEM TA6V Ø36/14, Ø40+3 CUP, GLENOID BASEPLATE, CENTERED GLENOSPHERE AND TWO LOCKING SCREW. NO PRODUCT IMPLANTED.
Patient problems: Bacterial Infection; Failure of Implant
MAUDE report 13167500 ↗InjuryDec 23, 2021Appropriate Device Problem Term/Code Not Available
PATIENT WAS REVISED ON (B)(6) 2021 DUE TO A DISLOCATION. APPROXIMATELY ONE MONTH AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED HUMERAL CUP 40+3 AND IMPLANTED STABILITY CUP 40+6.
Patient problems: Joint Dislocation
MAUDE report 13072435 ↗InjuryDec 15, 2021Appropriate Device Problem Term/Code Not Available
PATIENT WAS REVISED ON (B)(6) 2021 DUE TO REVISION FOR INFECTION. APPROXIMATELY ONE MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED HUMERAL CUP Ø 40+3, CENTERED CLENOSPHERE, STANDARD SCREW AND LOCKING SCREW. THE SURGEON IMPLANTED HUMERAL CUP Ø 40+3, CENTERED CLENOSPHERE, STANDARD SCREW AND TWO LOCKING SCREW.
Patient problems: Unspecified Infection
MAUDE report 13010441 ↗InjuryMar 16, 2021Adverse Event Without Identified Device or Use Problem
THE EVENT WAS A REVISION FOR INFECTION. THE SURGEON HAS EXPLANTED THE 40+3 HUMERAL CUP AND THE ¿40 CENTERED GLENOSPHERE AND HAS IMPLANTED A NEW ¿40 CENTERED GLENOSPHERE AND A 40+9 HUMERAL CUP.
Patient problems: Unspecified Infection
MAUDE report 11493974 ↗InjuryMar 2, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION FOR DISLOCATION. SUSPICION THAT THE PATIENT HAS FALLEN. PLACEMENT OF AN ENHANCER AND A 36+6 CUP, AS WELL AS AN ECCENTRIC 36 GLENOSPHERE.
Patient problems: Failure of Implant; Joint Dislocation
MAUDE report 11398772 ↗InjuryFeb 24, 2021Appropriate Device Problem Term/Code Not Available
REVISION BECAUSE PATIENT HAVE POLYARTHRITIS. SURGEON EXPLANTED THE STANDARD CUP 40+3 AND REPLACE BY STANDARD CUP 36+9.
Patient problems: Arthritis
MAUDE report 11371146 ↗
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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