Humelock II Cemented Reversible Shoulder 314-0706Recalls & reported problems
Fx Solutions · HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +6 · 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
- 9
- Deaths reported
- 0
- Injuries reported
- 9
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 03701037301517), received between Aug 2, 2021 and Aug 6, 2025 — classified as 9 injuries.
The most frequently reported specific device problem is “Microbial Contamination of Device” (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 Problem4
- Microbial Contamination of Device2
- Device Dislodged or Dislocated1
- Insufficient Device Problem Information1
- Unstable1
Patient problems
- Joint Dislocation3
- Medical device site infection3
- Failure of Implant1
- Subluxation1
- Unspecified Infection1
Recent adverse event reports
The 9 most recent of 9 reports, in the reporter's own words as published by the FDA.
InjuryAug 6, 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 22724805 ↗InjuryNov 6, 2023Adverse 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) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 18073229 ↗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 (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 17947832 ↗InjuryJul 6, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6)2023. A CUP, A GLENOSPHERE WERE EXPLANTED. A CUP, A GLENOSPHERE WERE IMPLANTED.
Patient problems: Subluxation
MAUDE report 17266053 ↗InjuryJul 6, 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, A GLENOSPHERE, A METAGLENE, SCREWS, SMARTAPS, SMARTLOOPS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, SMARTAPS, SMARTLOOPS, POST EXTENSION AND A STEM WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 17265233 ↗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) 2023. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, AND SCREW WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 16680513 ↗InjuryApr 4, 2022Device Dislodged or Dislocated
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 3 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 STEM HUMÉRIS 10, 1 ECCENTRIC GLENOSPHERE, 1 HUMERAL CUP 40+6 AND 1 GLENOID BASEPLATE. THE SURGEON IMPLANTED 1 HUMERAL CUP 135/145° Ø40+3, 1 GLENOSPHERE, 1 GLENOID BASEPLATE, 1 POST EXTENSION, 1 STEM HUMELOCK II, 2 CORTICAL SCREW, 1 STANDARD SCREW AND 2 LOCKING SCREW.
Patient problems: Failure of Implant
MAUDE report 13994217 ↗InjuryMar 2, 2022Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. THE SURGEON EXPLANTED 1 HUMERAL CUP 135/145° Ø40+6 AND 1 CENTERED GLENOSPHERE. THE SURGEON IMPLANTED 1 HUMERAL CUP 135/145° Ø40+6 AND 1 CENTERED GLENOSPHERE Ø40MM.
Patient problems: Unspecified Infection
MAUDE report 13652519 ↗InjuryAug 2, 2021Insufficient Device Problem Information
THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED APPROXIMATELY 1 WEEK AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMELOCK II REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø40/+6 135/145 HUMERAL CUP AND REPLACED IT BY A Ø40/+9 135/145 STABILITY HUMERAL CUP.
Patient problems: Joint Dislocation
MAUDE report 12257987 ↗
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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