Shoulder System 04.01.0124Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 07630040706315), received between Mar 8, 2019 and Jun 9, 2026 — classified as 26 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 26 reports, in the reporter's own words as published by the FDA.

• InjuryJun 9, 2026Device Dislodged or Dislocated

  AT ABOUT 1 WEEK FROM THE PRIMARY,THE PATIENT PRESENTED WITH DISLOCATION OF THE LINER FROM THE GLENOSPHERE; THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. FOLLOWING THE PRIMARY SURGERY, THE PATIENT EXPERIENCED MULTIPLE DISLOCATIONS, WHICH WERE TREATED BY CLOSED REDUCTION. THE LINER, METAPHYSIS, AND GLENOSPHERE WERE REVISED. THE SURGEON ELECTED TO UPSIZE THE GLENOSPHERE, THE METAPHYSIS AND TO IMPLANT A 42/0 CONSTRAINED LINER TO ACHIEVE OPTIMAL STABILITY AND RANGE OF MOTION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25442521 ↗
• InjuryJan 12, 2026Device 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 AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24031974 ↗
• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 22410975 ↗
• InjuryJun 10, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 4 MONTHS 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 METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22175047 ↗
• InjuryMar 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED 2 DAYS AFTER THE PRIMARY SURGERY DUE TO JOINT LUXATION (DISLOCATION GLENOSPHERE FROM LINER). METAPHYSIS AND LINER REVISED. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21664959 ↗
• InjuryOct 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DISLOCATION BETWEEN LINER AND GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, BASEPLATE, SCREWS AND INSERT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20522342 ↗
• InjuryOct 11, 2024Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  AT 2 WEEKS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO DEVELOPING A HEMATOMA AND THE CAUSE IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Hematoma

  MAUDE report 20426057 ↗
• InjurySep 19, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20256798 ↗
• InjuryAug 23, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN WAS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER, STEM AND GLENOSPHERE. ON (B)(6) 2024, 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 20049146 ↗
• InjuryApr 15, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2024, 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, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19105969 ↗
• InjuryMar 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. AT ABOUT 4 YEARS AND 4 MONTHS POST PRIMARY THE SURGEON REVISED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18864595 ↗
• InjuryJan 31, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 8 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18612542 ↗
• InjuryJan 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 11 MONTHS AFTER 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 METAPHYSIS, GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18525666 ↗
• InjuryDec 1, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY FOR SHOULDER LUXATION 5 DAYS AFTER PRIMARY. INTRAOPERATIVELY, THE STEM COULD BE REMOVED RELATIVELY EASILY AND IT WAS REPLACED AS WELL.

  Patient problems: Joint Dislocation

  MAUDE report 18244578 ↗
• InjuryNov 2, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2023. ON (B)(6) 2023, 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 THE SURGERY WAS COMPLETED SUCCESSFULLY. ON (B)(6) 2023, THE PATIENT HAD A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 18055001 ↗
• InjuryJul 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 WEEK AFTER THE PRIMARY, THE PATIENT CAME 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: Implant Pain

  MAUDE report 17316013 ↗
• InjuryDec 19, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A PRIMARY ANATOMICAL SHOULDER SURGERY ON (B)(6) 2019. SUBSEQUENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A TORN ROTATOR CUFF. ON (B)(6) 2022, THE SURGEON REVISED THE ANATOMICAL SHOULDER TO A REVERSE SHOULDER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE REVERSE METAPHYSIS, LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 16004173 ↗
• InjuryOct 3, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER THE PRIMARY, A REVISION SURGERY WAS PERFORMED DUE TO LUXATION OCCURRED DURING SHOULDER MOVEMENT. THE SURGEON REVISED SUCCESSFULLY THE LINER, GLENOSPHERE AND METAPHYSIS.

  Patient problems: Joint Dislocation

  MAUDE report 15526926 ↗
• InjuryAug 18, 2022Device Dislodged or Dislocated

  DURING POST-OPERATIVE RECOVERY THE DAY AFTER THE PRIMARY SURGERY, THE PATIENT REPORTED PAIN DUE TO DISLOCATION. THE SURGEON REVISED THE LINER, METAPHYSIS, DIAPHYSIS, AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 15247647 ↗
• InjuryAug 10, 2022Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Unspecified Infection

  MAUDE report 15199312 ↗
• InjuryJun 14, 2022Device Dislodged or Dislocated

  ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT WAS REVISED DUE TO JOINT DISLOCATION (ALL COMPONENTS REVISED EXCEPT FOR THE BASEPLATE). ABOUT 20 DAYS AFTER THE FIRST REVISION, THE JOINT DISLOCATED AGAIN DURING PHYSIOTHERAPY (METAPHYSIS AND LINER REVISED). DURING THIS REVISION, IT WAS NOTED THAT THE PROSTHESIS WAS NOT REDUCING BECAUSE OF SOFT AND RESIDUAL TISSUES (EG OF TRACHITIS) THAT INTERPOSED IN THE POSTERIOR PART AND KEPT THE JOINT DISLOCATED ANTERIORLY.

  Patient problems: Joint Dislocation

  MAUDE report 14684867 ↗
• InjuryDec 16, 2020Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED 2 MONTHS AFTER THE PRIMARY SURGERY DUE TO DISLOCATION OF THE PROSTHESIS. THE SURGEON REVISED THE METAPHYSIS AND THE INSERT. THE EVENT WAS CAUSED DUE TO THE PATIENT WAS TOO ACTIVE IN PHYSIOTHERAPY AND EVERYDAY LIFE. THE MEDACTA SHOULDER WAS IMPLANTED TO REPLACE A COMPETITOR SYSTEM IN A VERY COMPLICATED SURGERY. THE BROKEN SCREW VISIBLE ON THE X-RAY IS A PART OF COMPETITOR'S PROSTHESIS PREVIOUSLY EXPLANTED.

  Patient problems: Joint Dislocation

  MAUDE report 11019542 ↗
• InjurySep 3, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY SURGERY ON THE (B)(6) 2020. ON THE (B)(6) 2020 A REVISION SURGERY FOR UNKNOWN REASON WAS NECESSARY. ON THE (B)(6) 2020 (2 MONTHS AFTER PRIMARY AND 1 ONE AFTER THE FIRST REVISION) THE PATIENT SHOULDER WAS REVISED AGAIN FOR DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE SURGEON REVISED SUCCESSFULLY THE GLENOSPHERE, THE LINER AND THE METHAPHYSIS.

  Patient problems: Joint Dislocation

  MAUDE report 10487361 ↗
• InjuryFeb 13, 2020Unstable; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED DUE TO SHOULDER INSTABILITY, AN ANATOMIC PROSTHESIS HAS BEEN USED TO REPLACE REVERSE DEVICES. THE PATIENT WAS ALREADY REVISED DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 9706057 ↗
• InjuryDec 13, 2019Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN COMPLAINING OF PAIN DUE TO A DISLOCATION OF THE SHOULDER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE GLENOID BASEPLATE, THE HUMERAL METAPHYSIS, GLENOSPHERE, AND ALL GLENOID SCREWS 2 MONTHS AFTER PRIMARY SURGERY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Disorder

  MAUDE report 9464994 ↗