Humelock II Cemented Reversible Shoulder 105-0024Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 03701037300237), received between Mar 19, 2021 and Oct 2, 2024 — classified as 1 death, 27 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 25 most recent of 28 reports, in the reporter's own words as published by the FDA.

• InjuryOct 2, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OCCURRED APPROXIMATELY 5 MONTHS AFTER THE PRIOR SURGERY WHICH OCCURRED ON (B)(6) 2024. THE PRIMARY SURGERY OCCURRED ON (B)(6) 2023. NO FALL OR OTHER TRAUMA REPORTED. REVISION OCCURRED DUE TO DISLOCATION OF UNKNOWN CAUSE. 24 MM GLENOID BASEPLATE, 36 MM ECCENTRIC GLENOSPHERE, 36 MM + 9 HUMERAL STABILITY CUP, AND 3 LOCKING SCREWS EXPLANTED. THESE PARTS WERE REPLACED WITH AN OFFSET 54X21 HEAD AND 24 MM ECCENTRIC TAPER ADAPTER.

  Patient problems: Joint Dislocation

  MAUDE report 20351658 ↗
• InjuryNov 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN INFECTION ON 24TH OCTOBER 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2023. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. A CUP, A GLENOSPHERE, A METAGLENE AND A STEM WERE IMPLANTED.

  Patient problems: Medical device site infection

  MAUDE report 18197955 ↗
• InjuryOct 18, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SCREWS AND CONSTRUCT FAILED DURING NORMAL USE APPROXIMATELY TWO WEEKS AFTER IMPLANTATION. PATIENT NOTES THAT THEY FELT A POP (NO PAIN REPORTED), RESULTING IN A DISLOCATION. SCREWS FROM INITIAL SURGERY DEEMED TOO SHORT BY THE SURGEON. STANDARD SCREWS, FXV135 BASEPLATE, 36 MM GLENOSPHERE, AND 36 MM + 3 HUMERAL CUP EXPLANTED. CONVERSION TO HEMI.

  Patient problems: Joint Dislocation

  MAUDE report 17958334 ↗
• InjuryMay 24, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISMANTLING ON (B)(6) 2023. THE IMPLANTATION DATE WAS ON (B)(6) 2022. A GLENOSPHERE, A METAGLENE AND SCREWS WERE EXPLANTED. A METAGLENE WAS IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 16990576 ↗
• InjuryDec 14, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO A DIS-ASSOCIATION ON (B)(6) 2022. THE PRIMARY SURGERY WAS PROBABLY IN (B)(6) 2022. A CUP, A METAGLENE AND GLENOSPHERE WERE EXPLANTED. A CUP, A GLENOSPHERE AND A METAGLENE WERE IMPLANTED.

  Patient problems: Joint Laxity

  MAUDE report 15975826 ↗
• InjuryApr 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR THE SECOND TIME DUE TO NOTCHING/PAIN. THE DETAILS ON PREVIOUS SURGERIES ARE AS BELOW 1ST REVISION - (B)(6) 2021 (MDR # 3014128390-2021-00032) PRIMARY SURGERY - (B)(6) 2021. THE SURGEON EXPLANTED A GLENOID BASEPLATE (24), CENTERED GELNOSPHERE (36), 2 STANDARD SCREWS (20MM AND 25 MM EACH) AND A HUMERAL CUP (36/6). A POST-EXTENSION (6MM), GLENOID ASEPLATE (24), ECCENTRIC GELNOSPHERE (36), HUMERAL CUP (36/3), HUMERAL SPACER (9) AND 2 STANDARD SCREWS (30MM AND 25 MM EACH) WERE IMPLANTED.

  Patient problems: Pain

  MAUDE report 14196964 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO STATE PATIENT. APPROXIMATELY 7 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 GLENOID BASEPLATE (24), 1 CENTERED GLENOSPHERE (36), 1 HUMERIS STEM (13), 1 HUMERAL CUP (36/3), 2 STANDARD SCREWS (40, 15) AND 2 LOCKING SCREWS (20). THE SURGEON IMPLANTED 1 OFFSET HEAD (54X21) AND 1 CENTERED SPACER (5).

  Patient problems: Insufficient Information

  MAUDE report 13900965 ↗
• InjuryMar 25, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2021 FOR INFECTION. APPROXIMATELY 1 MONTH AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 3 STANDARD SCREW (4.5/25MM, 4.5/40MM AND 4.5/30MM), 2 LOCKING SCREW (4.5/40MM AND 4.5/20MM), 1 HUMERAL CUP (40/6), 1 GLENOID BASEPLATE (24MM), 1 CENTERED GLENOSPHERE (40/10) AND 1 HUMELOCK REVERSED STEM CEMENTLESS (40/14).

  Patient problems: Unspecified Infection

  MAUDE report 13898731 ↗
• InjuryMar 18, 2022Break; Loose or Intermittent Connection

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO BREAKING OF THE SCREW, BASEPLATE LOOSENING AND BONE LOSS. THE SURGEON EXPLANTED THE GLENOID BASEPLATE (24), CENTERED GLENOSPHERE (36), HUMERAL CUP (36/3), 2 STANDARD SCREWS (40MM AND 15MM) AND 2 LOCKING SCREWS (20MM EACH), RETAINING THE HUMERIS STEM (13) AND IMPLANTED AN OFFSET HEAD (54X21) AND A CENTERED SPACER (5).

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

  MAUDE report 13806419 ↗
• InjuryMar 14, 2022Device Dislodged or Dislocated

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO DISLOCATION. THE SURGEON EXPLANTED A HUMERAL CUP (32/9), GLENOID BASEPLATE (24), CENTERED GLENOSPHERE (32), 2 CORTICAL SCREWS (24), A STANDARD SCREW (30), AND 3 LOCKING SCREWS (15MM, 20 MM AND 26MM), RETAINING THE HUMELOCK II STEM AND IMPLANTED AN OFFSET HEAD (46X18) AND A DOUBLE TAPER (0).

  MAUDE report 13762840 ↗
• InjuryMar 3, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR INFECTION. APPROXIMATELY 167 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 2 LOCKING SCREW, 1 HUMERAL CUP 135/145° Ø36+3, 1 CENTERED GLENOSPHERE, 1 GLENOID BASEPLATE, 1 STEM AND 2 COTICAL SCREW. THE SURGEON IMPLANTED 1 CENTERED GLENOSPHERE WITH SCREW Ø36MM, 1 GLENOID BASEPLATE, 1 HUMELOCK STEM II SIZE 8, 1 STANDARD SCREW, 2 LOCKING SCREW AND 2 CORTICAL SCREW.

  Patient problems: Unspecified Infection

  MAUDE report 13657902 ↗
• InjuryFeb 7, 2022Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2022 DUE TO A INFECTION. APPROXIMATELY 237 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED STEM 32/10, Ø 36+3 CUP, CENTERED GLENOSPHERE, TWO LOCKING SCREW, TWO STANDARD SCREW AND GLENOID BASEPLATE. THE SURGEON IMPLANTED TWO CORTICAL SCREW, TWO LOCKING SCREW, TWO STANDARD SCREW, ECCENTRIC GLENOSPHERE, Ø40+9 CUP, GLENOID BASEPLATE AND Ø 36/12 STEM.

  Patient problems: Unspecified Infection

  MAUDE report 13469473 ↗
• InjuryFeb 3, 2022Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO A INFECTION, APPROXIMATELY 6 YEARS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED HUMERIS STEM SIZE 12, 135/145° Ø40+3 CUP, CENTERED GLENOSPHERE, TWO LOCKING SCREW, TWO STANDARD SCREW AND GLENOID BASEPLATE. THE SURGEON IMPLANTED HUMERIS STEM SIZE 10, 135/145° Ø40+3 CUP, CENTERED GLENOSPHERE, TWO LOCKING SCREW, TWO STANDARD SCREW AND GLENOID BASEPLATE.

  Patient problems: Unspecified Infection

  MAUDE report 13441892 ↗
• InjuryJan 31, 2022Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE PATIENT WAS REVISED ON (B)(6) 2022 FOR LOOSENING. APPROXIMATELY 1 YEAR AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 GLENOID BASEPLATE, 1 ECCENTRIC GLENOSHERE 36MM, 1 HUMERAL CUP 36+3, 1 STANDARD SCREW AND 2 LOCKING SCREW. THE SURGEON IMPLANTED 1 OFFSET TAPER ADAPTER AND 1 OFFSET HEAD 46*18.

  Patient problems: Insufficient Information

  MAUDE report 13390960 ↗
• InjuryJan 28, 2022Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO A INFECTION. APPROXIMATELY 9 WEEKS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED TWO STANDARD SCREW, LOCKING SCREW, CORTICAL SCREW, CENTERED GLENOSPHERE, STEM Ø36/14, Ø40+6 CUP AND GLENOID BASEPLATE. THE SURGEON IMPLANTED TWO LOCKING SCREW, TWO STANDARD SCREW, GLENOID BASEPLATE, CENTERED GLENOSPHERE, Ø36/14 STEM Ø40+3 AND POST EXTENSION.

  Patient problems: Unspecified Infection

  MAUDE report 13384719 ↗
• InjuryJan 5, 2022Device Dislodged or Dislocated

  THE PATIENT WAS REVISED ON (B)(6) 2021, APPROXIMATELY 6 WEEKS AFTER THE PRIMARY SURGERY ON (B)(6) 2021 DUE TO A DISLOCATION. THE HUMERAL CUP (36/3) AND HUMERIS STEM CEMENTLESS WERE EXPLANTED AND A HUMERAL CUP (36/3) AND HUMERIS STEM CEMENTLESS WERE IMPLANTED.

  Patient problems: Failure of Implant

  MAUDE report 13166921 ↗
• InjuryDec 27, 2021Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO A INFECTION, APPROXIMATELY 8 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 4 LOCKING SCREW, CENTERED GLENOSPHERE, Ø40+3 CUP, Ø40/12 STEM, GLENOID BASEPLATE. THE SURGEON IMPLANTED THREE LOCKING SCREW, POST EXTENSION, GLENOID BASEPLATE, CENTERED GLENOSPHERE, Ø40+3 CUP AND Ø40/12 STEM

  Patient problems: Unspecified Infection

  MAUDE report 13086902 ↗
• InjuryDec 17, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED ON (B)(6) 2021 DUE TO INFECTION. APPROXIMATELY ONE MONTH AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED GLENOID BASEPLANTE, GLENOSPHERE WITH SCREW, HUMERAL CUP Ø40+3, STEM TA6V SIZE 10. THE SURGEON IMPLANTED GLENOID BASEPLANTE, POST EXTENSION, TWO STANDARD SCREW, TWO LOCKING SCREW, 135/145° Ø40+6 CUP, HUMERIS STEM TA6V SIZE 10.

  Patient problems: Bacterial Infection

  MAUDE report 13025537 ↗
• DeathDec 15, 2021Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO INFECTION. APPROXYMATELY 5 MONTHS AFTER THE FIRST SURGERY. SURGEON EXPLANTED CEMENTLESS GLENOID BASE, STEM TAV6 SIZE 10, HUMERAL CUP 135/145° 36+3, TWO STANDARD SCREW, TWO LOCKED SCREW, TWO CORTICAL SCREW AND CENTERED GLENOID. SURGEON IMPLANTED CEMENTLESS GLENOID BASE, STEM TAV6 SIZE 10, HUMERAL CUP 135/145° 36+3, TWO STANDARD SCREW, TWO LOCKED SCREW, TWO CORTICAL SCREW AND CENTERED GLENOID.

  Patient problems: Unspecified Infection

  MAUDE report 13009689 ↗
• InjuryNov 19, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PATIENT WAS REVISED ON (B)(6) 2021 DUE TO DISLOCATION. APPROXIMATELY 3 MONTHS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED CENTERED GLENOSPHRE, GLENOID BASEPLATE, SCREW , Ø135/145 40+6 CUP, HUMERIS STEM SIZE 14. THE SURGEON IMPLANTED DOUBLE TAPER AND HELMET HEAD.

  Patient problems: Insufficient Information

  MAUDE report 12842413 ↗
• InjurySep 10, 2021Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO DISMANTLING DUE TO A FALL THAT OCCURED APPROXIMATELY 4 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMELOCK REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø40 ECCENTRIC GLENOSPHERE, THE Ø24 BASEPLATE, THE Ø40/+6 STANDARD HUMERAL CUP, THE +10MM POST EXTENSION AND ASSOCIATED SCREWS. THEN, HE IMPLANTED A Ø36 ECCENTRIC GLENOSPHERE, A Ø24 BASEPLATE, A Ø36/+6 STANDARD HUMERAL CUP, A +10MM POST EXTENSION AND ASSOCIATED SCREWS.

  Patient problems: Fall

  MAUDE report 12452021 ↗
• InjuryAug 5, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO LOOSENING THAT OCCURED APPROXIMATELY 5 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø40/+3 135/145 HUMERAL CUP, THE Ø40 ECCENTRIC GLENOSPHERE, THE Ø24 BASEPLATE, THE 10MM POST EXTENSION AND ASSOCIATED SCREWS. THEN HE IMPLANTED A NEW Ø24 BASEPLATE, A NEW 10MM POST EXTENSION, A Ø40 CENTERED GLENOSPHERE, A Ø40/+6 135/145 HUMERAL CUP AND ASSOCIATED SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 12279182 ↗
• InjuryAug 5, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THIS EVENT WAS A REVISION SURGERY DUE TO DISLOCATION THAT OCCURED 10 DAYS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. DURING THE REVISION SURGERY, THE SURGEON EXPLANTED THE Ø40/+9 135/145 HUMERAL CUP, THE Ø24 BASEPLATE, THE Ø40 CENTERED GLENOSPHERE AND ASSOCIATED SCREWS. THEN HE IMPLANTED A Ø40/+6 135/145 HUMERAL CUP, A 10MM POST EXTENSION, A NEW Ø24 BASEPLATE, A NEW Ø40 CENTERED GLENOSPHERE AND ASSOCIATED SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 12279173 ↗
• 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 2 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMAR SURGERY USED THE HUMERIS REVERSED SYSTEM. THE SURGEON EXPLAINED THE LOOSENING OF THE BASEPLATE WAS COMING FROM A TOO HIGH BONE GRAFT THAT MADE IT UNSTABLE. THE SURGEON EXPLANTED THE Ø24 BASEPLATE AND THE 10MM POST EXTENSION AND THEY WERE REPLACED BY THE SAME PRODUCTS. HE EXPLANTED THE Ø36/+3 135/145 HUMERAL CUP AND REPLACED IT BY A Ø40/+3 135/145 HUMERAL CUP. HE EXPLANTED ALSO THE Ø36 CENTERED GLENOSPHERE AND REPLACED IT BY A Ø40 CENTERED GLENOSPHERE. HE ALSO EXPLANTED ASSOCIATED SCEWS.

  Patient problems: Insufficient Information

  MAUDE report 11892142 ↗
• InjuryMay 27, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  THE EVENT WAS A REVISION SURGERY DUE TO THE GLENOSPHERE LOOSENING THAT OCCURED APPROXIMATELY 3 MONTHS AFTER THE PRIMARY SURGERY. THE PRIMARY SURGERY USED THE HUMERIS REVERSED SYSTEM. THE SURGEON EXPLANTED THE 36/+3 135/145 HUMERAL CUP, THE 36 CENTERED GLENOSPHERE, THE 24 BASEPLATE, THE +10MM POST EXTENSION AND ASSOCIATED SCREWS. THEN HE IMPLANTED A 40/+6 135/145 HUMERAL CUP, A 40 CENTERED GLENOSPHERE, A +10MM POST EXTENSION, A 24 BASEPLATE AND ASSOCIATED SCREWS.

  Patient problems: Insufficient Information

  MAUDE report 11892133 ↗