Humelock II Cemented Reversible Shoulder 313-0703Recalls & reported problems
Fx Solutions · HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3 · Class 2 · Implant
All models of Humelock II Cemented Reversible Shoulder (23)
Data updated Oct 18, 2026 from official FDA records · Editorial policy
Quick summary
This Humelock II reverse shoulder prosthesis has 40 adverse event reports naming its identifier; all 40 describe injuries, with no deaths. Reports mostly describe joint dislocation and infection, with some implant breakage or fracture. No recalls name this device.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 40
- Deaths reported
- 0
- Injuries reported
- 40
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 03701037301357), received between Mar 26, 2021 and Jun 8, 2026 — classified as 40 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (12 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
- Appropriate Device Problem Term/Code Not Available19
- Adverse Event Without Identified Device or Use Problem12
- Device Dislodged or Dislocated12
- Unstable4
- Break2
- Fracture1
- Microbial Contamination of Device1
Patient problems
- Insufficient Information12
- Joint Dislocation11
- Medical device site infection5
- Unspecified Infection5
- Subluxation3
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Damage to Ligament(s)1
- Implant Pain1
Recent adverse event reports
The 25 most recent of 40 reports, in the reporter's own words as published by the FDA.
InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO AN INFECTION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2026. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 25426565 ↗InjuryFeb 16, 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) 2026. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 24342816 ↗InjuryDec 15, 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 23801210 ↗InjuryJun 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 22158938 ↗InjuryApr 3, 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 21759963 ↗InjuryJan 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISLOCATION. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 21264576 ↗InjuryNov 13, 2024Adverse 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) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 20671983 ↗InjurySep 16, 2024Break; Break
THE PATIENT WAS REVISED DUE TO BROKEN IMPLANT ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON 23TH DECEMBER 2013. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Implant Pain
MAUDE report 20223089 ↗InjuryJun 17, 2024Adverse 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) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 19547096 ↗InjuryMar 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2024. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 18920739 ↗InjuryFeb 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT REVISED APPROXIMATELY 6 MONTHS AFTER PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION. 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH 36 MM + 6 STABILITY HUMERAL CUP.
Patient problems: Joint Dislocation
MAUDE report 18722360 ↗InjuryJan 11, 2024Adverse 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 18491250 ↗InjurySep 14, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO A DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A CUP, A GLENOSPHERE, A METAGLENE, SCREWS, A SMARTAPE, SMARTLOOPS, A POST EXTENSION AND AN OFFSET MODULAR SYSTEM WERE EXPLANTED. AN HELMET HEAD AND A DOUBLE TAPER WERE IMPLANTED.
Patient problems: Subluxation
MAUDE report 17742902 ↗InjuryAug 1, 2023Unstable; Unstable
THE PATIENT WILL BE REVISED DUE TO AN INSTABILITY ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP MAY BE EXPLANTED. A CUP COULD BE IMPLANTED.
Patient problems: Damage to Ligament(s)
MAUDE report 17432934 ↗InjuryMay 29, 2023Unstable; Unstable
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: Subluxation
MAUDE report 17016362 ↗InjuryMay 3, 2023Unstable; Unstable
THE PATIENT WAS REVISED DUE TO DISLOCATION ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2019. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Subluxation
MAUDE report 16860989 ↗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 WERE EXPLANTED. A CUP WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 16680257 ↗InjuryJun 1, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 6 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 GLENOSPHERE, 1 HUMERAL CUP AND 1 STEM. THE SURGEON IMPLANTED 1 GLENOSPHERE, 1 HUMERAL CUP AND 1 STEM.
Patient problems: Joint Dislocation
MAUDE report 14563824 ↗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 7 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 CENTERED GLENOSPHERE, 3 LOCKING SCREW, 1 STANDARD SCREW, 1 GLENOID BASEPLATE AND 1 HUMERAL CUP 135/145° Ø36+3. THE SURGEON IMPLANTED 1 DOUBLE TAPER AND 1 HELMET HEAD.
Patient problems: Insufficient Information
MAUDE report 14116827 ↗InjuryApr 4, 2022Break
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISMANTLING. APPROXIMATELY 2 YEARS AND 1 MONTH AFTER THE LAST SURGERY. THE SURGEON EXPLANTED 1 STEM HUMELOCK II, 1 GLENOSPHERE, 1 GLENOID BASEPLATE, 2 STANDARD SCREW, 2 LONCKING SCREW AND 1 HUMERAL CUP 135/145° Ø36+3. THE SURGEON IMPLANTED 1 DOUBLE TAPER AND 1 CENTERED HEAD 43X16.
Patient problems: Insufficient Information
MAUDE report 13994316 ↗InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATELY 3 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP 135/145° Ø36+3, 1 OFFSET MODULAR SYSTEM, 1 STEM HUMELOCK II, 1 GLENOID BASEPLATE, 2 STANDARD SCREW, 2 LOCKING SCREW, 1 CENTERED GLENOSPHERE, 2 CORTICAL SCREW AND 1 SCREW. THE SURGEON IMPLANTED 1 GLENOID BASEPLATE, 1 CENTERED GLENOSPHERE, 2 LOCKING SCREW, 2 STANDARD SCREW, 1 STEM HUMELOCK II, 2 CORTICAL SCREW AND 1 HUMERAL CUP 135/145° Ø36+3.
Patient problems: Unspecified Infection
MAUDE report 13993499 ↗InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INFECTION. APPROXIMATELY 1 YEARS AND 7 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 3 STANDARD SCREW, 1 HUMERAL CUP 135/145 Ø36+3, 1 CENTERED GLENOSPHERE, 1 GLENOID BASEPLATE, 1 STEM HUMELOCK II, 2 CORTICAL SCREW AND 2 LOCKING SCREW. THE SURGEON IMPLANTED 1 CENTERED GLENOSPHERE, 2 STANDARD SCREW, 1 LOCKING SCREW, 1 STEM HUMELOCK II, 1 GLENOID BASEPLATE, 1 BASEPLATE GLENOID SCREW AND 1 HUMERAL CUP 135/145 Ø36+9.
Patient problems: Unspecified Infection
MAUDE report 13993363 ↗InjuryMar 29, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 21 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP 135/145° Ø36+3. THE SURGEON IMPLANTED 1 HUMERAL CUP 135/145° Ø36+6.
Patient problems: Joint Dislocation
MAUDE report 13937668 ↗InjuryMar 29, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 13 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP 135/145° Ø36+3. THE SURGEON IMPLANTED 1 HUMERAL CUP 135/145° STABILITY Ø40+9.
Patient problems: Joint Dislocation
MAUDE report 13937594 ↗InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available
PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INSTABILITY. APPROXIMATELY 2 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED Ø36+3 CUP, POST EXTENSION, GLENOID BASEPLATE AND CENTERED GLENOSPHERE. THE SURGEON IMPLANTED CENTERED GLENOSPHERE, TWO STANDARD SCREW, ONE LOCKING SCREW, Ø40+6 CUP, POST EXTENSION AND GLENOID BASEPLATE.
Patient problems: Insufficient Information
MAUDE report 13469532 ↗
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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