Shoulder System 04.01.0119Recalls & reported problems

Summary

The FDA's MAUDE database contains 52 adverse event reports that list this exact device (DI 07630040706261), received between Jan 16, 2019 and Sep 9, 2026 — classified as 52 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (32 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.

Most reported problems

Recent adverse event reports

The 25 most recent of 52 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Dislodged or Dislocated

  At about 1 month from the primary, the patient came in presenting pain due to dislocation of the liner from the glenosphere while making bed. The surgeon revised the D 36x24.5 glenosphere to a D 39x24.5 glenosphere, the metaphysis to a same size metaphysis and the D 36/+0mm liner to a D 39/+5mm liner. The surgery was completed successfully.

  Patient problems: Joint Dislocation

  MAUDE report 50692315 ↗
• InjurySep 9, 2026Device Dislodged or Dislocated

  On (b)(6) 2021, the patient had primary shoulder surgery. On (b)(6) 2022, the patient came in reporting pain due to a failed rotator cuff, and the cause of the failed rotator cuff is unknown. The surgeon converted the patient to a reverse shoulder and implanted a competitor glenoid component. The surgery was completed successfully. Presently, on (b)(6) 2026, the patient came in presenting pain due to joint luxation. There was no indication of trauma or fall. During the revision, the metaphysis screw was found loose. The surgeon revised the +9mm/0° metaphysis to a same size metaphysis and revised the D 36/+0 reverse liner to a D 36/+6 constrained liner. The surgery was completed successfully.

  Patient problems: Joint Dislocation

  MAUDE report 50692286 ↗
• InjuryMay 22, 2026Device Dislodged or Dislocated

  AT ABOUT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE TO A DISLOCATION OF THE LINER AND GLENOSPHERE AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON REVISED THE REVERSE METAPHYSIS, REVERSE LINER, AND GLENOSPHERE, REPLACING EACH WITH COMPONENTS OF THE SAME SIZE. NO LOOSE COMPONENTS WERE OBSERVED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25253496 ↗
• InjuryMay 5, 2026Device Appears to Trigger Rejection

  REVISION SURGERY DUE TO NICKEL ALLERGY AFTER ABOUT 1 YEAR AND 6 MONTHS AFTER PRIMARY SURGERY. THE SURGEON REVISED THE GLENOSPHERE TO A SENSITIN GLENOSPHERE AND THE INSERT TO A SAME SIZE INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 25077214 ↗
• InjuryFeb 20, 2026Device Dislodged or Dislocated

  THE SURGEON REPORTED THAT THE PROSTHESIS HAS DISLOCATED. THIS IS A CUSTOM-MADE CASE. THE CUSTOM-MADE GLENOID IS STILL IN PLACE; HOWEVER, THE SHOULDER IS DISLOCATED. ON (B)(6) 2026, A REVISION SURGERY WAS PERFORMED. THE SURGEON REVISED THE LINER AND THE ENTIRE HUMERAL SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 24399528 ↗
• InjuryDec 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DUE A DISLOCATION OF THE GLENOSPHERE FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED FROM A +0 LINER TO A +3 LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23858479 ↗
• InjuryNov 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23669501 ↗
• InjuryAug 27, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO JOINT LUXATION ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY. DURING THE REVISION, WHILE POSITIONING THE GLENOSPHERE, THE SURGEON NOTICED THAT THE BASEPLATE WAS LOOSE DUE TO A FRACTURE OF THE GLENOID AND DECIDED TO CONVERT THE IMPLANT TO AN HEMI.

  Patient problems: Bone Fracture(s)

  MAUDE report 22902797 ↗
• InjuryJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE POLY AND UPSIZED TO A +3MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT SHOULD BE NOTED THAT THE COUPLING OF GRS BASEPLATE FULL WEDGE WITH A LATERALIZED GLENOSPHERE IS NOT REGISTERED FOR USE.

  Patient problems: Joint Dislocation

  MAUDE report 22518026 ↗
• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22410999 ↗
• InjuryJul 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT SHOULDER HAD PAIN, INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 10 MONTHS FORM PRIMARY, THE SURGEON UPSIZED POLY (Ø36/+6MM) AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22384191 ↗
• InjuryJun 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION DUE TO INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. AT ABOUT 8 DAYS POST PRIMARY THE SURGEON REVISED THE LINER, IMPLANTING A THICKER ONE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 22269536 ↗
• InjuryJun 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22175019 ↗
• InjuryMay 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO JOINT LUXATION AT ABOUT 1 MONTH AND A HALF POST PRIMARY. LINER, GLENOSPHERE AND METAPHYSIS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 22042348 ↗
• InjuryNov 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PAIN DUE TO A DISLOCATION (OF THE GLENOSPHERE FROM THE LINER) AND THE CAUSE IS UNKNOWN. THE SAME DAY OF PRIMARY THE SURGEON REVISED THE LINER AND THE STEM. THE SURGERY WAS COMPLETED SUCCESSFULLY. NO ISSUES WITH THE REVISED DEVICES. THE STEM CHANGE IS REPORTED TO BE ONLY A GEOMETRIC MATTER TO INCREASE THE PROSTHESIS PERFORMANCE.

  Patient problems: Joint Dislocation

  MAUDE report 20674531 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT REPORTED SHOULDER INSTABILITY AND THE CAUSE IS UNKNOWN. AT ABOUT 11 MONTHS FROM THE PRIMARY THE SURGEON REVISED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 20180517 ↗
• InjuryMay 3, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD AN INFECTION AND THE PATHOGEN IS UNKNOWN. AT ABOUT 1 MONTH AND A HALF POST PRIMARY SURGERY THE SURGEON REMOVED THE HUMERAL INSERT, GLENOSPHERE, HUMERAL PROXIMAL BODY, AND WASHED OUT THE JOINT, TREATED WITH ANTIBIOTICS AND NEW IMPLANTS WERE RE-IMPLANTED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 19236213 ↗
• InjuryApr 30, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 3 YEARS AND 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 19211479 ↗
• InjuryJan 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 7 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LATERALIZED GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 18613586 ↗
• InjuryDec 19, 2023Migration; Migration

  ABOUT 1 YEAR AND 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT EXPERIENCED TWO EPISODES OF SPONTANEOUS DISLOCATION. PRE-REVISION TESTING BY THE SURGEON WITH EXCELLENT STABILITY IN ALL MOVEMENTS. POSTERIOR DISLOCATION ONCE THE PATIENT IS ASLEEP WITH MUSCLE RELAXATION. LINER REVISED WITH A HUMERAL REVERSE PE LINER 36MM +6MM (155).

  Patient problems: Joint Dislocation

  MAUDE report 18356297 ↗
• InjuryOct 10, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS, LINER, AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 17904607 ↗
• InjuryAug 9, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A SHOULDER HEMI-ARTHROPLASTY SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE PATIENT TO A REVERSE SHOULDER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS, LINER, AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17489208 ↗
• InjuryAug 4, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 6 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE LINER, GLENOSPHERE, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17458449 ↗
• InjuryJul 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 17396870 ↗
• InjuryJul 25, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  REVISION SURGERY AT ABOUT 1 MONTH AND 10 DAYS AFTER PRIMARY FOR INFECTION, THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Medical device site infection

  MAUDE report 17387949 ↗