Humelock II Cemented Reversible Shoulder 313-0706Recalls & reported problems
Fx Solutions · HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +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
- 21
- Deaths reported
- 0
- Injuries reported
- 21
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 03701037301364), received between Feb 23, 2021 and May 5, 2026 — classified as 21 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 Available11
- Device Dislodged or Dislocated5
- Adverse Event Without Identified Device or Use Problem3
- Detachment of Device or Device Component3
- Unstable3
- Loose or Intermittent Connection2
Patient problems
- Insufficient Information7
- Failure of Implant4
- Joint Dislocation4
- Medical device site infection2
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available1
- Joint Laxity1
- Subluxation1
- Unspecified Infection1
Recent adverse event reports
The 21 most recent of 21 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 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 WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 25079583 ↗InjuryNov 27, 2024Adverse 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) 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: Medical device site infection
MAUDE report 20793863 ↗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 17016400 ↗InjuryDec 2, 2022Detachment of Device or Device Component; Detachment of Device or Device Component
THE PATIENT WAS REVISED DUE TO A DIS-ASSOCIATION ON (B)(6) 2022. THE PRIMARY SURGERY WAS IN (B)(6) 2022. A CUP WAS EXPLANTED. A NEW CUP WAS IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 15904824 ↗InjuryAug 3, 2022Unstable
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO INSTABILITY, APPROXIMATELY 1170 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP 36+6. THE SURGEON IMPLANTED 1 REVERSED ADAPTER AND 1 HUMERAL CUP 36+9.
Patient problems: Failure of Implant
MAUDE report 15155495 ↗InjuryJul 7, 2022Unstable
THE PATIENT WAS REVISED DUE TO INSTABILITY ON (B)(6) 2022, FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2019. THE SURGEON EXPLANTED THE HUMERAL CUP (36/6) AND IMPLANTED A HUMERAL CUP (36/9) AND A REVERSED ADAPTER.
Patient problems: Failure of Implant
MAUDE report 14944805 ↗InjuryApr 8, 2022Device Dislodged or Dislocated
THE PATIENT WAS REVISED ON (B)(6) 2022 FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2017 DUE TO DISLOCATION. THE SURGEON EXPLANTED A STANDARD HUMERAL CUP (36/6) AND IMPLANTED A STABILITY HUMERAL CUP (36/6).
Patient problems: Joint Dislocation
MAUDE report 14056687 ↗InjuryApr 4, 2022Device Dislodged or Dislocated
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 15 DAYS AFTER THE LAST SURGERY AND 36 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP 135/1445° Ø36+6 AND 1 CENTERED GLENOSPHERE. THE SURGEON IMPLANTED 1 CENTERED GLENOSPHERE AND 1 HUMERAL CUP 135/145° Ø36+6.
Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available
MAUDE report 13994720 ↗InjuryApr 4, 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° Ø36+6 AND 1 CENTERED GLENOSPHERE. THE SURGEON IMPLANTED 1 CENTERED GLENOSPHERE AND 1 HUMERAL CUP 135/145 Ø36+6.
Patient problems: Unspecified Infection
MAUDE report 13994621 ↗InjuryApr 4, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO DISLOCATION. APPROXIMATELY 4 YEARS AND 9 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 HUMERAL CUP (36/6). THE SURGEON IMPLANTED 1 HUMERAL CUP (36/6).
Patient problems: Joint Dislocation
MAUDE report 13994453 ↗InjuryJan 31, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 04 YEARS AFTER THE PRIMARY SURGERY ON (B)(6) 2017. THE CAUSE FOR REVISION IS UNKNOWN. THE SURGEON EXPLANTED THE STANDARD HUMERAL CUP (36/6) AND IMPLANTED A STABILITY HUMERAL CUP (36/9).
Patient problems: Insufficient Information
MAUDE report 13391274 ↗InjuryJan 5, 2022Detachment of Device or Device Component
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 3 WEEKS AFTER THE PRIMARY SURGERY ON (B)(6) 2021 AS THE HUMERAL CUP GOT DISENGAGED FROM THE HUMERIS STEM. THE DISENGAGED HUMERAL CUP (36/6) WAS EXPLANTED AND A NEW HUMERAL CUP (36/6) WAS IMPLANTED.
Patient problems: Failure of Implant
MAUDE report 13167522 ↗InjuryJan 4, 2022Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 04 YEARS AFTER THE PRIMARY SURGERY ON (B)(6) 2017. THE CAUSE FOR REVISION IS UNKNOWN. THE SURGEON EXPLANTED THE STANDARD HUMERAL CUP (36/6) AND IMPLANTED A STABILITY HUMERAL CUP (36/9).
Patient problems: Insufficient Information
MAUDE report 13158525 ↗InjuryDec 10, 2021Detachment of Device or Device Component; Appropriate Device Problem Term/Code Not Available
THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 3 WEEKS AFTER THE PRIMARY SURGERY ON (B)(6) 2021 AS THE HUMERAL CUP GOT DISENGAGED FROM THE HUMERIS STEM. THE DISENGAGED HUMERAL CUP (36/6) WAS EXPLANTED AND A NEW HUMERAL CUP (36/6) WAS IMPLANTED.
Patient problems: Insufficient Information
MAUDE report 12980855 ↗InjuryOct 8, 2021Appropriate Device Problem Term/Code Not Available
THIS EVENT WAS A REVISION FOR DISLOCATION. APPROXIMATELY TWO MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMELOCK II REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPANTED THE Ø 36+6 135/145 HUMERAL CUP. THEN, HE IMPLANTED Ø 36+6 STABILITY HUMERAL CUP.
Patient problems: Joint Dislocation
MAUDE report 12598099 ↗InjuryAug 30, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED APPROXIMATELY 3 WEEKS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø36/+3 135/145 HUMERAL CUP AND REPLACED IT BY A Ø36/+9 135/145 HUMERAL CUP.
Patient problems: Insufficient Information
MAUDE report 12382652 ↗InjuryAug 9, 2021Appropriate Device Problem Term/Code Not Available
THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED APPROXIMATELY ONE MONTH AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMELOCK II REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø36/+6 135/145 HUMERAL CUP AND REPLACED IT BY A Ø36/+6 135/145 STABILITY HUMERAL CUP.
Patient problems: Joint Dislocation
MAUDE report 12292511 ↗InjuryMay 27, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
THE EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED APPROXIMATELY 1 MONTH AFTER THE PRIMARY SURGERY. THE PRIMAR SURGERY USED THE HUMELOCK II REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø36 CENTERED GLENOSHERE AND THE 135/145 Ø36/+6 HUMERAL CUP. THEN HE IMPLANTED Ø40 ECCENTRIC GLENOSHERE AND A 135/145 Ø40/+9 HUMERAL CUP.
Patient problems: Insufficient Information
MAUDE report 11892145 ↗InjuryMay 27, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
THE EVENT WAS A REVISION SURGERY DUE TO LOOSENING THAT OCCURED APPROXIMATELY 4 YEARS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMELOCK II REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø36/+6 HUMERAL CUP. HE IMPLANTED MEDICAL DEVICES FROM A COMPETING COMPANY.
Patient problems: Insufficient Information
MAUDE report 11892143 ↗InjuryMar 30, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available
PATIENT REVISED ON (B)(6) 2021 DUE TO INSTABILITY, APPROXIMATELY 2 YEARS AFTER PRIMARY SURGERY. SURGEON EXPLANTED THE 135/145 36/+6 HUMERAL CUP AND THEN IMPLANTED A 36/+6 STANDARD HUMERAL CUP AND A 135/145 REVERSED ADAPTER FOR AN EXTRA +9MM OF SPACING.
Patient problems: Failure of Implant
MAUDE report 11588085 ↗InjuryFeb 23, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available
REVISION FOR DISLOCATION. DURING THE FIRST POSE, PROBLEM WITH THE ANAESTHETIST, SHOULDER TOO RELAXED. THE SURGEON REPLACED THE 36+6 HUMERAL CUP WITH A 36+9 CUP.
Patient problems: Insufficient Information
MAUDE report 11363970 ↗
Other Shoulder Prosthesis, Reverse Configuration devices
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- 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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