Humelock II Cemented Reversible Shoulder 105-3610Recalls & reported problems
Fx Solutions · HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 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
Quick summary
This FX Solutions Humelock II is a reverse-configuration shoulder implant used in total shoulder replacement. The 62 reports mostly describe the joint coming apart or slipping out of place, the implant shifting position, infection at the surgical site, and the bone-implant bond loosening, often leading to a second operation to swap parts, with no falls or trauma involved. There were no deaths, 62 injuries, and no recalls name this device. Reports in the past 12 months dropped to 4 from 10.
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
- 64
- Deaths reported
- 0
- Injuries reported
- 64
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 64 adverse event reports that list this exact device (DI 03701037300268), received between Mar 19, 2021 and Sep 24, 2026 — classified as 64 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 Problem29
- Appropriate Device Problem Term/Code Not Available16
- Device Dislodged or Dislocated9
- Migration4
- Unstable3
- Material Separation2
- Break1
- Disconnection1
Patient problems
- Joint Dislocation16
- Medical device site infection10
- Insufficient Information9
- Joint Laxity8
- Failure of Implant5
- Inadequate Osseointegration4
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available3
- Fall3
Recent adverse event reports
The 25 most recent of 64 reports, in the reporter's own words as published by the FDA.
InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Revision occurred on (b)(6) 2026 approximately after 49 days after the primary surgery which happened on (b)(6) 2026. No fall or trauma was reported. Based on comparing usage forms, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø36mm and HUMERAL CUP STABILITY PE/TA6V Ø36/+3was explanted due to dislocation. This part was replaced with HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40mm and HUMERAL CUP STABILITY PE/TA6V Ø40/+3. FX V135® HUMELOCK STEM TA6V Ø36/14 L. 120MM CEMENTLESS Ti/HA was not replaced.
Patient problems: Joint Dislocation
MAUDE report 50885541 ↗InjurySep 24, 2026Adverse Event Without Identified Device or Use Problem
Revision occurred on (b)(6) 2026 approximately after 105 days after the primary surgery which happened on (b)(6) 2026. No fall or trauma was reported. Based on comparing usage forms, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø36mm, FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +3 and FX V135 HUMERAL SPACER TA6V +9mm was explanted due to dislocation. This part was replaced HUMERAL CUP STANDARD PE/TA6V Ø40/+6, HUMERAL SPACER TA6V +9mm and HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø40mm. FX V135® HUMELOCK STEM TA6V Ø36/12 L. 120MM CEMENTLESS Ti/HAwas not replaced.
Patient problems: Joint Dislocation
MAUDE report 50884877 ↗InjuryJul 2, 2026Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO DISASSEMBLY ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2026. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP, A GLENOSPHERE, AND HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 25691129 ↗InjuryJun 12, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026 APPROXIMATELY 105 DAYS AFTER THE PRIMARY WHICH OCCURRED ON (B)(6) 2026. NO FALL OR OTHER TRAUMA WAS REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø36 MM AND HUMERAL CUP STANDARD PE/TA6V Ø36/+ WAS EXPLANTED DUE TO INSTABILITY AND REPLACED WITH HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø40 MM AND FX V135 HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +6. FX V135 STEM TA6V Ø36/16 CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Joint Laxity
MAUDE report 25488201 ↗InjuryMay 29, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026 APPROXIMATELY 399 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA WAS REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø36MM AND HUMERAL CUP STANDARD PE/TA6V Ø36/+6 WAS EXPLANTED DUE TO DISLOCATION AND REPLACED WITH HUMERAL CUP STABILITY PE/TA6V Ø36/+9, HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TIN 10° TILT Ø36MM AND FX V135 HUMERAL SPACER TA6V +9MM. FX V135® HUMELOCK STEM TA6V Ø36/12 L. 120MM CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Joint Dislocation
MAUDE report 25337501 ↗InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 8 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT THE IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 3 HUMERAL STABILITY CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 6 HUMERAL STABILITY CUP.
Patient problems: Medical device site infection
MAUDE report 23791411 ↗InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 10 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 3 STANDARD HUMERAL CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE AND A 40 MM + 9 135/145* STABILITY HUMERAL CUP.
Patient problems: Joint Dislocation
MAUDE report 23327972 ↗InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 4 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 36 MM CENTERED GLENOSPHERE, 36 MM + 3 STANDARD HUMERAL CUP, AND 9 MM SPACER WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM ECCENTRIC GLENOSPHERE, 40 MM + 9 STANDARD HUMERAL CUP, AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 22963790 ↗InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 11 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 36 MM CENTERED GLENOSPHERE WAS EXPLANTED AND REPLACED WITH A 36 MM ECCENTRIC GLENOSPHERE.
Patient problems: Joint Dislocation
MAUDE report 22512185 ↗InjuryMay 15, 2025Migration; Migration
REVISION OCCURRED APPROXIMATELY 4 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO SURGEON ERROR; ACCORDING TO THE DISTRIBUTOR, THE SURGEON "DID NOT SEAT THE GLENOSPHERE CORRECTLY AND THE SCREW WAS NOT TIGHT". 36 MM +3 STANDARD HUMERAL CUP AND 36 MM CENTERED GLENOSPHERE EXPLANTED. THESE PARTS WERE REPLACED WITH A CENTERED 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STABILITY HUMERAL CUP.
Patient problems: Inadequate Osseointegration
MAUDE report 22029524 ↗InjuryMay 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 9 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT THE IMPLANT SITE. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE AND 36 MM + 6 STANDARD HUMERAL CUP.
Patient problems: Medical device site infection
MAUDE report 21997990 ↗InjuryApr 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 4 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO SUSPECTED INFECTION PRESENTING AS SWELLING. THE PATIENT HAS HAD KNOWN PREVIOUS INFECTION AT THIS SITE TREATED BY MEANS OTHER THAN REVISION OF FX PRODUCT. 36 MM CENTERED GLENOSPHERE AND 36 MM + 9 HUMERAL STANDARD CUP EXPLANTED. THESE PARTS WERE REPLACED WITH 36 MM CENTERED GLENOSPHERE, 36 MM + 6 HUMERAL STABILITY CUP, AND 9 MM SPACER.
Patient problems: Medical device site infection
MAUDE report 21936039 ↗InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 5 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT THE IMPLANT SITE. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 HUMERAL STANDARD CUP. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 HUMERAL STANDARD CUP.
Patient problems: Medical device site infection
MAUDE report 21663759 ↗InjuryJan 29, 2025Migration; Migration
REVISION OCCURRED APPROXIMATELY 4 YEARS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2021. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO LOOSENING OF GLENOID COMPONENTS. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP WERE EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM + 3 CENTERED GLENOSPHERE AND A 36 MM + 6 STANDARD HUMERAL CUP. REVISION OCCURRED APPROXIMATELY 4 YEARS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2021. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO LOOSENING OF GLENOID COMPONENTS. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP WERE EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM + 3 CENTERED GLENOSPHERE AND A 36 MM + 6 STANDARD HUMERAL CUP.
Patient problems: Inadequate Osseointegration
MAUDE report 21267658 ↗InjuryJan 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 2 WEEKS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. A 36 MM CENTERED GLENOSPHERE AND A 36 MM + 9 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE, 36 MM + 9 HUMERAL STABILITY CUP, AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 21161546 ↗InjuryDec 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 3 WEEKS AFTER THE PRIOR REVISION, WHICH OCCURRED ON (B)(6) 2024. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. CENTERED 36 MM GLENOSPHERE, 36 MM + 3 HUMERAL STABILITY CUP, AND 9 MM SPACER EXPLANTED. THESE PARTS WERE REPLACED WITH IDENTICAL PARTS.
Patient problems: Medical device site infection
MAUDE report 20854874 ↗InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 6 DAYS AFTER THE PRIOR REVISION SURGERY, WHICH OCCURRED ON (B)(6) 2024. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2024. THE PRIOR REVISION OCCURRED DUE TO AN UNKNOWN CAUSE. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO AN INFECTION AT IMPLANT SITE. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STABILITY HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STABILITY HUMERAL CUP.
Patient problems: Medical device site infection
MAUDE report 20353718 ↗InjuryMay 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO LOOSENING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A GLENOSPHERE WAS EXPLANTED. A GLENOSPHERE WAS IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 19400617 ↗InjuryMay 15, 2024Migration; Migration
REVISION OCCURRED APPROXIMATELY 6 YEARS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2018. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISSOCIATION OF THE GLENOSPHERE. 36 MM GLENOSPHERE AND 36 MM + 6 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP.
Patient problems: Inadequate Osseointegration
MAUDE report 19320483 ↗InjuryMay 15, 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) 2023. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 19319791 ↗InjuryApr 30, 2024Migration; Migration
REVISION OCCURRED APPROXIMATELY 3 WEEKS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO LOOSENING OF THE GLENOSPHERE. 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH IDENTICAL PARTS.
Patient problems: Inadequate Osseointegration
MAUDE report 19215670 ↗InjuryApr 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WILL BE REVISED DUE TO PAIN AND LOOSENING ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2023.
Patient problems: Implant Pain
MAUDE report 19069556 ↗InjuryMar 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED APPROXIMATELY 9 MONTHS AFTER THE PRIOR REVISION SURGERY, WHICH OCCURRED ON (B)(6) 2023. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION SURGERY OCCURRED DUE TO INSTABILITY WITH A POSSIBLE INFECTION. 36 MM CENTERED GLENOSPHERE AND 36 MM + 9 HUMERAL STABILITY CUP EXPLANTED. THESE PARTS WERE REPLACED WITH 36 MM ECCENTRIC GLENOSPHERE, 36 MM + 6 HUMERAL STABILITY CUP, AND 9 MM SPACER.
Patient problems: Medical device site infection
MAUDE report 18875259 ↗InjuryMar 8, 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 18866153 ↗InjuryMar 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
PATIENT WAS REVISED ON (B)(6) 2024, APPROXIMATELY 2 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO RECURRING DISLOCATIONS AND INFECTION AT IMPLANT SITE. 36 MM CENTERED GLENOSPHERE, 36 MM + 9 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH A 40 MM ECCENTRIC GLENOSPHERE, REVERSE ADAPTER, AND 40 MM + 6 HUMERAL STABILITY CUP IMPLANTED. INCISION AND DRAINAGE PERFORMED FOR INFECTION, ANTIBIOTIC BEADS ALSO APPLIED.
Patient problems: Medical device site infection
MAUDE report 18837608 ↗
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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