Humelock II Cemented Reversible Shoulder 103-0803Recalls & reported problems
Fx Solutions · HUMERAL CUP STANDARD PE/TA6V Ø36/+3 · Class 2 · Implant
Quick summary
This FX Solutions Humelock II reversible shoulder is a cemented shoulder joint implant. The 83 reports list 83 injuries and no deaths. Many describe dislocation, joint looseness and infections, with several revision surgeries replacing cups, glenospheres or spacers. 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
- 84
- Deaths reported
- 0
- Injuries reported
- 84
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 84 adverse event reports that list this exact device (DI 03701037300091), received between Feb 9, 2021 and Sep 10, 2026 — classified as 84 injuries.
The most frequently reported specific device problem is “Device Dislodged or Dislocated” (13 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem36
- Appropriate Device Problem Term/Code Not Available21
- Device Dislodged or Dislocated13
- Unstable11
- Fracture2
- Break1
- Improper or Incorrect Procedure or Method1
- Loose or Intermittent Connection1
Patient problems
- Joint Dislocation18
- Joint Laxity15
- Unspecified Infection13
- Medical device site infection11
- Insufficient Information10
- Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available6
- Subluxation4
- Fall3
Recent adverse event reports
The 25 most recent of 84 reports, in the reporter's own words as published by the FDA.
InjurySep 10, 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 50715517 ↗InjuryJul 30, 2026Adverse Event Without Identified Device or Use Problem
Revision was performed on (b)(6)2026 approximately 71 days after the primary surgery which happened on (b)(6)2026. No fall or other trauma was reported. Based on the information available, only HUMERAL CUP STANDARD PE/TA6V Ø36/+3 was explanted due to instability and replaced with HUMERAL CUP STABILITY PE/TA6V Ø36/+6. FX V135 STEM TA6V Ø36/14 CEMENTLESS Ti/HA was not replaced.
Patient problems: Joint Laxity
MAUDE report 50087410 ↗InjuryJun 15, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026. ALL REQUIRED INFORMATION WAS RECEIVED ON 09-JUN-2026. REVISION OCCURED APPROXIMATELY 252 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA WAS REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMERAL CUP STANDARD PE/TA6V Ø36/+3 WAS EXPLANTED DUE TO DISLOCATION AND REPLACED WITH HUMERAL CUP STABILITY PE/TA6V Ø36/+3 AND FX V135 HUMERAL SPACER TA6V +9MM. FX V135® HUMELOCK STEM TA6V Ø32/08 L. 120MM CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Joint Dislocation
MAUDE report 25505619 ↗InjuryMay 12, 2026Migration or Expulsion of Device
THE PATIENT WAS REVISED DUE TO GLENOID LOOSENING SECONDARY TO AN INFECTION ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2026. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A POST EXTENSION WERE EXPLANTED. A HEAD AND A POST EXTENSION WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 25147058 ↗InjuryApr 14, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED ON (B)(6) 2026, APPROXIMATELY 308 DAYS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2025. NO FALL OR OTHER TRAUMA REPORTED. BASED ON COMPARING USAGE FORMS ONLY HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V/TIN 10° TILT Ø36 MM AND HUMERAL CUP STANDARD PE/TA6V Ø36/+3 WAS EXPLANTED DUE TO INSTABILITY. THESE PARTS WERE REPLACED WITH HUMELOCK REVERSED CENTERED GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø40 MM AND HUMERAL CUP 135/145° STABILITY PE/TA6V Ø40 +9. FX V135 STEM TA6V Ø36/16 CEMENTLESS TI/HA WAS NOT REPLACED.
Patient problems: Joint Laxity
MAUDE report 24874572 ↗InjuryJan 23, 2026Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 2 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 + 3 STANDARD HUMERAL CUP AND A 9 MM SPACER WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 36 MM + 6 HUMERAL STABILITY CUP AND A 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 24167397 ↗InjuryNov 13, 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 WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 23540928 ↗InjuryOct 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 15 DAYS 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 + 3 STANDARD HUMERAL CUP WAS EXPLANTED. THIS ITEM WAS REPLACED WITH A 36 MM + 6 135/145* HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 23324674 ↗InjuryOct 17, 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: Joint Dislocation
MAUDE report 23320960 ↗InjuryOct 16, 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 23310295 ↗InjuryJul 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 7 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 + 3 HUMERAL STANDARD CUP WAS EXPLANTED AND REPLACED WITH A 36 MM + 9 HUMERAL STABILITY CUP.
Patient problems: Joint Dislocation
MAUDE report 22536509 ↗InjuryJun 19, 2025Adverse 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) 2025. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 22292422 ↗InjuryJun 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO GLÉNOSPHÈRE DISMANTLING ON (B)(6) 2025. THE IMPLANTATION DATE WAS ON 2017. A CUP AND A GLÉNOSPHÈRE WERE EXPLANTED. A CUP AND A GLÉNOSPHÈRE WERE IMPLANTED.
Patient problems: Joint Laxity
MAUDE report 22165435 ↗InjuryApr 22, 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 WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 21884178 ↗InjuryJan 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 18 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT THE IMPLANT SITE. 36 MM + 3 HUMERAL STANDARD CUP EXPLANTED AND REPLACED WITH 36 MM + 9 HUMERAL STANDARD CUP.
Patient problems: Medical device site infection
MAUDE report 21183542 ↗InjuryNov 21, 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 AND A REVERSED ADAPTER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 20745944 ↗InjuryNov 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WILL BE REVISED DUE TO DISLOCAION ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2023.
Patient problems: Joint Dislocation
MAUDE report 20608069 ↗InjuryOct 31, 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) 2019. A CUP AND A GLENOSPHERE WERE EXPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 20578074 ↗InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 13 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION. 36 MM +3 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH AN IDENTICAL PART. NO FURTHER INFORMATION WAS PROVIDED BY THE REPRESENTATIVE AFTER THREE ATTEMPTS TO GATHER SUCH INFORMATION.
Patient problems: Medical device site infection
MAUDE report 20501175 ↗InjuryOct 21, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
REVISION OCCURRED APPROXIMATELY 7 DAYS AFTER THE PRIOR REVISION SURGERY WHICH OCCURRED ON (B)(6) 2024. PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION. 36 MM +3 STANDARD HUMERAL CUP EXPLANTED AND REPLACED WITH A 36 MM + 3 135/145 STANDARD HUMERAL CUP. NO FURTHER INFORMATION WAS PROVIDED BY THE REPRESENTATIVE AFTER THREE ATTEMPTS TO GATHER SUCH INFORMATION.
Patient problems: Medical device site infection
MAUDE report 20500487 ↗InjuryOct 7, 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 AND A HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 20381908 ↗InjuryOct 1, 2024Adverse 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) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 36 MM + 3 STABILITY HUMERAL CUP EXPLANTED AND REPLACED WITH A 36 MM + 6 HUMERAL STABILITY CUP AND 9 MM SPACER.
Patient problems: Joint Dislocation
MAUDE report 20344550 ↗InjurySep 27, 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 AND HUMERAL SPACER WERE IMPLANTED.
Patient problems: Joint Dislocation
MAUDE report 20321117 ↗InjuryJul 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THE PATIENT WAS REVISED DUE TO PAIN ON (B)(6) 2024. THE IMPLANTATION DATE WAS ON (B)(6) 2021. A CUP, A GLENOSPHERE AND A METAGLENE WERE EXPLANTED. AN ECCENTRIC TAPER ADAPTER AND AN HELMET HEAD WERE IMPLANTED.
Patient problems: Implant Pain
MAUDE report 19816177 ↗InjuryJun 11, 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 WAS EXPLANTED. A CUP WAS IMPLANTED.
Patient problems: Medical device site infection
MAUDE report 19510168 ↗
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: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.