Humelock II Cemented Reversible Shoulder 105-3600Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED CENTERED GLENOSPHERE CoCr 10° TILT Ø36 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03701037300244), received between Sep 30, 2021 and Feb 5, 2024 — classified as 2 injuries.
The most frequently reported specific device problem is “Premature Separation” (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 Available1
- Premature Separation1
Patient problems
- Loss of Range of Motion1
- Unspecified Infection1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 5, 2024Premature Separation; Premature Separation
REVISION OCCURRED APPROXIMATELY 6 YEARS AFTER THE PRIMARY SURGERY, WHICH OCCURRED IN (B)(6) 2018. THE PRIMARY USAGE FORM WAS NOT ABLE TO BE LOCATED, AS THE PRODUCT WAS DISTRIBUTED THROUGH ANOTHER VENDOR. NO FALL OR OTHER TRAUMA REPORTED. THE CAUSE FOR THE REVISION WAS THE GLENOSPHERE DISASSOCIATING WITH THE BASEPLATE, SEEMINGLY OVER A LONG PERIOD OF TIME. SURGEON NOTES INDICATE MOBILITY AND RANGE OF MOTION HAD BEEN COMPROMISED. 36 MM CENTERED GLENOSPHERE AND 36 MM + 6 STANDARD HUMERAL CUP WERE EXPLANTED; THE INCLUDED PART NUMBERS ARE LIKELY BUT NOT ABSOLUTE AS NO PRIMARY USAGE FORM COULD BE OBTAINED. THESE PARTS WERE REPLACED WITH A 36 MM ECCENTRIC GLENOSPHERE, AND 36 MM + 6 HUMERAL STABILITY CUP.
Patient problems: Loss of Range of Motion
MAUDE report 18643926 ↗InjurySep 30, 2021Appropriate Device Problem Term/Code Not Available
THE EVENT WAS A REVISION SURGERY DUE TO INFECTION THAT OCCURED APPROXIMATELY 6 YEARS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMELOCK II REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE 135/145 Ø36/+3 HUMERAL CUP AND THE Ø36 CENTERED GLENOSPHERE. THEN, HE IMPLANTED A 135/145 Ø36/+9 HUMERAL CUP AND A Ø36 ECCENTRIC GLENOSPHERE.
Patient problems: Unspecified Infection
MAUDE report 12554126 ↗
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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