Humelock Reversed Shoulder 317-3208Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 03701037303696), received between Mar 19, 2021 and Aug 5, 2025 — classified as 7 injuries.

The most frequently reported specific device problem is “Loss of Osseointegration” (2 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 5, 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, A GLENOSPHERE, A METAGLENE AND A STEM WERE EXPLANTED. IMPLANT REMOVAL WITHOUT REPLACEMENT.

  Patient problems: Medical device site infection

  MAUDE report 22714096 ↗
• InjuryNov 7, 2023Migration; Migration

  REVISION WAS PERFORMED APPROXIMATELY 3 MONTHS AFTER PRIMARY SURGERY FOR BASEPLATE LOOSENING AND DISLOCATION. NO FALL OR OTHER TRAUMA NOTED. REVISION WAS A CONVERSION TO HEMI CONFIGURATION AS A RESULT OF DISLOCATION. PRIMARY SURGERY OCCURRED (B)(6) 2023. 32 MM CENTERED GLENOSPHERE, 32 MM + 3 STANDARD HUMERAL CUP, GLENOID BASEPLATE, AND 32/8 REVERSE STEM EXPLANTED. REPLACED WITH 36/12 LONG STEM, 48 MM OFFSET HEAD, AND 24/10 ECCENTRIC TAPER ADAPTER.

  Patient problems: Joint Dislocation

  MAUDE report 18088291 ↗
• InjurySep 20, 2022Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED DUE TO STEM LOOSENING ON (B)(6) 2022, FOLLOWING THE PRIMARY SURGERY ON (B)(6) 2021. THE SURGEON EXPLANTED THE HUMELOCK REVERSED STEM (32/08), A TAPER ADAPTER (24/10) AND OFFSET HEAD (46X18). A HUMELOCK REVERSED STEM (32/10), A TAPER ADAPTER (24/10) AND OFFSET HEAD (46X18) WERE IMPLANTED. THIS EVENT HAS BEEN FILED BY THE MANUFACTURER UNDER THE REPORT NUMBER 3009532798-2022-00128.

  Patient problems: Joint Laxity

  MAUDE report 15455507 ↗
• InjurySep 9, 2022Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT WAS REVISED ON (B)(6) 2022 DUE TO LOOSENING, APPROXIMATELY 392 DAYS AFTER THE FIRST SURGERY. THE SURGEON EXPLANTED 1 STEM 32/08, 1 TAPER ADAPTATER, 1 HEAD. THE SURGEON IMPLANTED 1 STEM 32/10, 1 TAPER ADAPTATER, 1 HEAD.

  Patient problems: Joint Laxity

  MAUDE report 15389153 ↗
• InjuryDec 3, 2021Device Dislodged or Dislocated

  PATIENT REVISED ON (B)(6) 2021 DUE TO MULTIPLE DISLOCATIONS FOLLOWING PRIMARY SURGERY ON (B)(6) 2021. SURGEON EXPLANTED THE 32/08 CEMENTLESS HR STEM AND 36/+9 STANDARD HUMERAL CUP, AND THEN IMPLANTED A 32/10 CEMENTLESS HR STEM, +9MM HUMERAL SPACER, AND 36/+9 STABILITY HUMERAL CUP.

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

  MAUDE report 12922309 ↗
• InjuryNov 25, 2021Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED ON (B)(6) 2021 DUE TO A FALL, APPROXIMATELY 5 WEEKS FOLLOWING PRIMARY SURGERY ON (B)(6) 2021. SURGEON REPLACED THE 32/08 CEMENTLESS HR STEM AND 36/+6 STANDARD HUMERAL CUP WITH A 32/12 CEMENTLESS LOCKABLE HR STEM AND 36/+3 STANDARD HUMERAL CUP.

  Patient problems: Fall

  MAUDE report 12873508 ↗
• InjuryMar 19, 2021Loose or Intermittent Connection; Appropriate Device Problem Term/Code Not Available

  PATIENT REVISED ON (B)(6) 2021 DUE TO A LOOSE STEM, APPROXIMATELY 1 YEAR AFTER PRIMARY SURGERY. SURGEON EXPLANTED THE 32/08 HUMELOCK REVERSE STEM, 36/+9 STANDARD HUMERAL CUP, AND +9MM HUMERAL SPACER, AND REPLACED THEM WITH A NEW 32/08 HUMELOCK REVERSE STEM SECURED WITH TWO CORTICAL SCREWS, A 36/+9 STABILITY HUMERAL CUP, AND A +9MM HUMERAL SPACER.

  Patient problems: Failure of Implant; Joint Laxity

  MAUDE report 11528037 ↗