Humelock II Cemented Reversible Shoulder 104-0809Recalls & reported problems
Fx Solutions · HUMERAL CUP STANDARD PE/TA6V Ø40/+9 · 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
- 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 03701037300145), received between Dec 10, 2021 and Nov 17, 2025 — 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 Problem3
- Appropriate Device Problem Term/Code Not Available3
- Device Dislodged or Dislocated1
Patient problems
- Joint Dislocation2
- Insufficient Information1
- Joint Laxity1
- Medical device site infection1
- Seroma1
- Unspecified Infection1
Recent adverse event reports
The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.
InjuryNov 17, 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) 2022. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 23566987 ↗InjuryJun 9, 2025Adverse 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) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP, A GLENOSPHERE AND A HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Laxity; Medical device site infection
MAUDE report 22166149 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 21 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. 40 MM + 9 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH A 40 MM + 7 STABILITY HUMERAL CUP AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 20855052 ↗InjuryApr 15, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 15 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 GLENOID BASEPLATE (24), 1 CENTERED GLENOSPHERE (40), 1 HUMERAL CUP (40/9), 1 STANDARD SCREW (40) AND 2 LOCKING SCREW (20 AND 40). THE SURGEON IMPLANTED 1 CEMENTED GLENOID BASEPLATE (24), 1 CENTERED GLENOSPHERE (40), 1 HUMERAL CUP (40/6), 2 STANDARS SCREW (20 AND 35), 1 CENTRAL SCREW (14) AND 2 LOCKING SCREW (30 AND 40).
Patient problems: Insufficient Information
MAUDE report 14116802 ↗InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 FOR INFECTION. APPROXIMATELY 2 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 GLE,OID BASEPLATE, 2 STANDARD SCREW (35MM AND 40MM), 1 POST EXTENSION +10MM, 1 HUMERAL SPACER AND 1 HUMERAL CUP 40+9.
Patient problems: Unspecified Infection
MAUDE report 13899065 ↗InjuryDec 10, 2021Appropriate Device Problem Term/Code Not Available
THE PATIENT DEVELOPED SEROMA WHICH LED TO A REVISION SURGERY ON (B)(6) 2021, APPROXIMATELY A WEEK AFTER THE PRIMARY SURGERY ON (B)(6) 2021 TO AVOID INFECTION. ONLY THE HUMERAL CUP (40/9) WAS REPLACED WITH A NEW HUMERAL CUP (40/9). THE EXPLANT WAS SENT FOR PATHOLOGY.
Patient problems: Seroma
MAUDE report 12980778 ↗
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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