Humelock II Cemented Reversible ShoulderRecalls & reported problems across all models

We found 23 models of Humelock II Cemented Reversible Shoulder by Fx Solutions in the FDA's device registry (GUDID). Together they are named in 406 adverse event reports in the FDA's MAUDE database, received between Feb 9, 2021 and Sep 24, 2026 — classified as 1 death, 404 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (68 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Humelock II Cemented Reversible Shoulder problems

Humelock II Cemented Reversible Shoulder models

23 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Humelock II Cemented Reversible Shoulder 103-0803

  Shoulder Prosthesis, Reverse Configuration
  84 reports
• Humelock II Cemented Reversible Shoulder 105-3610

  Shoulder Prosthesis, Reverse Configuration
  64 reports
• Humelock II Cemented Reversible Shoulder 313-0703

  Shoulder Prosthesis, Reverse Configuration
  40 reports
• Humelock II Cemented Reversible Shoulder 103-0806

  Shoulder Prosthesis, Reverse Configuration
  38 reports
• Humelock II Cemented Reversible Shoulder 105-0024

  Shoulder Prosthesis, Reverse Configuration
  1 death28 reports
• Humelock II Cemented Reversible Shoulder 313-0706

  Shoulder Prosthesis, Reverse Configuration
  21 reports
• Humelock II Cemented Reversible Shoulder 103-0809

  Shoulder Prosthesis, Reverse Configuration
  20 reports
• Humelock II Cemented Reversible Shoulder 104-0806

  Shoulder Prosthesis, Reverse Configuration
  15 reports
• Humelock II Cemented Reversible Shoulder 104-0803

  Shoulder Prosthesis, Reverse Configuration
  14 reports
• Humelock II Cemented Reversible Shoulder 105-4010

  Shoulder Prosthesis, Reverse Configuration
  14 reports
• Humelock II Cemented Reversible Shoulder 314-0703

  Shoulder Prosthesis, Reverse Configuration
  14 reports
• Humelock II Cemented Reversible Shoulder 313-0709

  Shoulder Prosthesis, Reverse Configuration
  11 reports
• Humelock II Cemented Reversible Shoulder 105-3613

  Shoulder Prosthesis, Reverse Configuration
  10 reports
• Humelock II Cemented Reversible Shoulder 314-0706

  Shoulder Prosthesis, Reverse Configuration
  9 reports
• Humelock II Cemented Reversible Shoulder 314-0709

  Shoulder Prosthesis, Reverse Configuration
  8 reports
• Humelock II Cemented Reversible Shoulder 104-0809

  Shoulder Prosthesis, Reverse Configuration
  6 reports
• Humelock II Cemented Reversible Shoulder 105-4011

  Shoulder Prosthesis, Reverse Configuration
  3 reports
• Humelock II Cemented Reversible Shoulder 105-3600

  Shoulder Prosthesis, Reverse Configuration
  2 reports
• Humelock II Cemented Reversible Shoulder 112-0100

  Shoulder Prosthesis, Reverse Configuration
  1 report
• Humelock II Cemented Reversible Shoulder 108-4520

  Shoulder Prosthesis, Reverse Configuration
  1 report
• Humelock II Cemented Reversible Shoulder 108-4525

  Shoulder Prosthesis, Reverse Configuration
  1 report
• Humelock II Cemented Reversible Shoulder 108-4540

  Shoulder Prosthesis, Reverse Configuration
  1 report
• Humelock II Cemented Reversible Shoulder 109-4525

  Shoulder Prosthesis, Reverse Configuration
  1 report

Recent Humelock II Cemented Reversible Shoulder adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 31, 2026Adverse Event Without Identified Device or Use Problem

  Revision occurred on (b)(6) 2026 approximately 465 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 ECCENTRIC GLENOSPHERE W/ SCREW CoCr/TA6V 10° TILT Ø36mm, HUMERAL CUP 135/145° STANDARD PE/TA6V Ø36 +9 and HUMELOCK REVERSED TA6V CEMENTLESS GLENOID BASEPLATE W/ SCREW Ti/HA Ø24mm, +3mm LATERALIZED was explanted due to dislocation and replaced with REVERSED ADAPTER TA6V 135/145,° HUMERAL CUP STABILITY PE/TA6V Ø36/+3, DOUBLE TAPER TA6V +0mm 0° and CENTERED HEAD CoCr 50x19.

  Patient problems: Joint Dislocation

  MAUDE report 50104916 ↗
• 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 ↗
• InjuryJul 13, 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 IMPLANTED. A CUP AND A GLENOSPHERE WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 25792337 ↗
• InjuryJul 6, 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, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE, SCREWS AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 25715681 ↗
• 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 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 SURGERY OCCURRED APPROXIMATELY 134 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 Ø40MM AND FX V135 HUMERAL CUP 135/145° STANDARD PE/TA6V Ø40 +3 WAS EXPLANTED DUE TO DISLOCATION AND REPLACED WITH HUMELOCK REVERSED ECCENTRIC GLENOSPHERE W/ SCREW COCR/TA6V 10° TILT Ø36MM, FX V135 HUMERAL SPACER TA6V +9MM AND FX V135 HUMERALCUP 135/145° STABILITY PE/TA6V Ø36 +3. FX V135® HUMELOCK STEM TA6V Ø36/12 L. 120MM CEMENTLESS TI/HA WAS NOT REPLACED.

  Patient problems: Joint Dislocation

  MAUDE report 25511107 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• InjuryMay 11, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INSTABILITY RESULTING FROM THE REMOVAL OF A GLENOSPHERE ON (B)(6) 2026. THE IMPLANTATION DATE WAS ON (B)(6) 2025. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE AND SCREWS WERE EXPLANTED. A CUP, A GLENOSPHERE, A GLENOID BASEPLATE AND SCREWS WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 25134831 ↗

Other Fx Solutions products

• TiN Coated Glenosphere5 models · 27 reports · 1 recall
• Humelock Cemented Shoulder Prosthesis7 models · 22 reports · 1 recall
• Humeral Cup Stability15 models · 65 reports
• Humeris Shoulder9 models · 35 reports
• Humelock Reversed Shoulder13 models · 32 reports
• Humelock II Cementless Shoulder System5 models · 26 reports
• Easytech Anatomical Shoulder System4 models · 24 reports
• Humelock II Cemented Shoulder System9 models · 20 reports