Humelock II Cemented Reversible Shoulder 105-4011Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40 mm · 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
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03701037300312), received between Jul 19, 2021 and May 16, 2025 — classified as 3 injuries.
The most frequently reported specific device problem is “Improper or Incorrect Procedure or Method” (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
- Improper or Incorrect Procedure or Method1
- Insufficient Device Problem Information1
- Loose or Intermittent Connection1
Patient problems
- Failure of Implant1
- Insufficient Information1
- Joint Laxity1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryMay 16, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method
REVISION OCCURRED APPROXIMATELY 16 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO LOOSENING OF THE GLENOSPHERE. 40 MM ECCENTRIC GLENOSPHERE EXPLANTED AND REPLACED WITH A 36 MM CENTERED GLENOSPHERE. NOTE THAT THIS IS CONTRARY TO THE SURGICAL TECHNIQUE, WHICH STATES THAT THE GLENOSPHERE AND HUMERAL CUP SHOULD BE OF THE SAME DIAMETER.
Patient problems: Joint Laxity
MAUDE report 22039759 ↗InjurySep 1, 2021Insufficient Device Problem Information
THE EVENT TOOK PLACE OUTSIDE OF THE UNITED STATES (IN (B)(6)) AND WAS ASSOCIATED WITH A PRODUCT THAT IS ALSO CLEARED FOR THE MARKET WITHIN THE UNITED STATES.
Patient problems: Insufficient Information
MAUDE report 12405574 ↗InjuryJul 19, 2021Loose or Intermittent Connection
THE EVENT WAS A REVISION SURGERY DUE TO ANCHOR BASE LOOSENING THAT OCCURED APPROXIMATELY 7 MONTHS AFTER THE PRIMARY SURGERY. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø38 ANCHOR BASE, THE Ø40 ECCENTRIC GLENOSPHERE AND THE Ø40/+6 HUMERAL CUP. THEN HE IMPLANTED A NEW Ø40 ECCENTRIC GLENOSPHERE, A SIZE 14 CEMENTLESS STEM AND A Ø40/+9 HUMERAL CUP.
Patient problems: Failure of Implant
MAUDE report 12188100 ↗
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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