Humelock II Cemented Reversible Shoulder 105-3613Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI 03701037300275), received between Mar 31, 2021 and Jul 31, 2026 — classified as 9 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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.

Most reported problems

Recent adverse event reports

The 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• 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 ↗
• InjurySep 19, 2025Migration; Migration

  REVISION OCCURRED APPROXIMATELY 43 WEEKS AFTER THE PRIMARY FX SURGERY, WHICH OCCURRED ON (B)(6) 2024. THE PRIMARY FX CASE WAS A REVISION OF COMPETITOR. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO THE GLENOSPHERE COMING LOOSE FROM THE BASEPLATE, UNSCREWING IS SPECIFICALLY MENTIONED AS THE MECHANISM OF LOOSENING. A 36 MM ECCENTRIC GLENOSPHERE AND A 36 MM + 3 STANDARD HUMERAL CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM ECCENTRIC GLENOSPHERE AND A 40 MM + 6 HUMERAL STABILITY CUP.

  Patient problems: Inadequate Osseointegration

  MAUDE report 23100228 ↗
• InjuryJul 15, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 6 MONTHS AFTER THE PRIMARY SURGERY, WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO INFECTION AT IMPLANT SITE. A 36 MM CENTERED GLENOSPHERE AND 36 MM + 3 HUMERAL STANDARD CUP WERE EXPLANTED. THESE ITEMS WERE REPLACED WITH A 40 MM CENTERED GLENOSPHERE AND A 40 MM + 9 STANDARD HUMERAL CUP.

  Patient problems: Medical device site infection

  MAUDE report 22512187 ↗
• MalfunctionApr 30, 2025Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  REVISION OCCURRED APPROXIMATELY 7 MONTHS AFTER THE PRIMARY SURGERY WHICH OCCURRED ON (B)(6) 2024. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISSOCIATION OF GLENOSPHERE FROM THE BASEPLATE. 36 MM ECCENTRIC GLENOSPHERE AND 36 MM + 3 HUMERAL STABILITY CUP. THESE PARTS WERE REPLACED WITH A 36 MM ECCENTRIC GLENOSPHERE AND 36 MM + 9 HUMERAL STANDARD CUP.

  Patient problems: Joint Laxity

  MAUDE report 21935081 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED APPROX. 6 MONTHS AFTER IMPLANTATION DATE, AS THE SURGEON NOTICED AN INFECTION AT THE IMPLANT SITE. ORIGINAL 36 MM GLENOPHERE AND 36 MM + 3 STANDARD HUMERAL CUP EXPLANTED. THESE PARTS WERE REPLACED WITH 36 MM GLENOPHERE AND 36 MM + 6 STABILITY HUMERAL CUP. INFECTION IS ONGOING AFTER REVISION.

  Patient problems: Medical device site infection

  MAUDE report 17950039 ↗
• InjuryMar 2, 2022Device Dislodged or Dislocated

  THE PATIENT WAS REVISED FOR DISLOCATION ON (B)(6) 2021. APPROXIMATELY 3 WEEKS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 ECCENTRIC GLENOSPHERE (36), 1 HUMERAL SPACER (9) AND 1 HUMERAL CUP (36/9). THE SURGEON IMPLANTED 2 CORTICAL SCREW 26 AND 28, 1 HUMERAL SPACER (9) AND 1 HUMERAL CUP (36/6).

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13652913 ↗
• InjuryMar 2, 2022Device Dislodged or Dislocated

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR DISLOCATION. APPROXIMATELY 4 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 ECCENTRIC GLENOSPHERE AND 1 HUMERAL CUP 135/145° Ø36+9. THE SURGEON IMPLANTED 1 ECCENTRIC GLENOSPHERE, 1 ADAPTER AND 1 STABILITY HUMERAL CUP Ø40+3.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 13652835 ↗
• InjuryJan 5, 2022Fracture; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2021 AFTER PRIMARY SURGERY ON (B)(6) 2021 FOR DISLOCATION DUE TO PROXIMAL HUMERAL FRACTURE. THE SURGEON EXPLANTED AN ECCENTRIC GLENOSPHERE (36), HUMERAL SPACER (9) AND HUMERAL CUP (36/9). THE SURGEON IMPLANTED 2 CORTICAL SCREWS (1 OF 28MM AND 26 MM EACH), ECCENTRIC GLENOSPHERE (40), HUMERAL SPACER (9) AND HUMERAL CUP (36/6).

  Patient problems: Insufficient Information

  MAUDE report 13172503 ↗
• InjuryMay 10, 2021Improper or Incorrect Procedure or Method; Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED FOR THIRD TIME DUE TO NON-COMPLIANCE WITH POST-SURGICAL INSTRUCTIONS ON (B)(6) 2021, APPROXIMATELY 5 WEEKS AFTER PRIMARY SURGERY. FIRST TWO REVISIONS PREVIOUSLY REPORTED. SURGEON EXPLANTED 36MM ECCENTRIC GLENOSPHERE WITH SCREW, 36/+9 STABILITY HUMERAL CUP, AND HUMELOCK REVERSED 36/14 CEMENTLESS LOCKABLE STEM. HE THEN IMPLANTED A 40MM ECCENTRIC GLENOSPHERE WITH SCREW AND HUMERAL SIDE COMPONENTS FROM ANOTHER MANUFACTURER, WHICH IS AN OFF-LABEL USE OF THE FX SHOULDER DEVICE.

  Patient problems: Insufficient Information

  MAUDE report 11796988 ↗
• InjuryMar 31, 2021Adverse Event Without Identified Device or Use Problem

  PATIENT REVISED ON (B)(6) 2021 DUE TO INFECTION, APPROXIMATELY 1 YEAR AFTER PRIMARY SURGERY. SURGEON CONVERTED REVERSE TO A HEMI, EXPLANTING ALL COMPONENTS EXCEPT FOR STEM (36/+3 STANDARD HUMERAL CUP, 36MM ECCENTRIC GLENOSPHERE WITH SCREW, 24MM GLENOID BASEPLATE, 2 STANDARD SCREWS, AND 2 LOCKING SCREWS), AND THEN IMPLANTING +0MM DOUBLE TAPER AND 39X14 CENTERED HUMERAL HEAD.

  Patient problems: Unspecified Infection

  MAUDE report 11594202 ↗