Shoulder System 04.01.0208Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 07630040728072), received between Mar 17, 2021 and Mar 5, 2026 — classified as 18 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryMar 5, 2026Device Dislodged or Dislocated

  ABOUT 4 MONTHS AND A HALF AFTER THE PRIMARY SURGERY, REVISION SURGERY WAS PERFORMED DUETO GLENOSPHERE SCREW UNSCREWING AND GLENOSPHERE DISSOCIATION FROM THE BASEPLATE.

  Patient problems: Joint Dislocation

  MAUDE report 24518510 ↗
• InjurySep 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY SHOULDER SURGERY ON (B)(6) 2025. THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLEOSPHERE. THE SURGEON REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, THE PATIENT CAME IN DUE TO ANOTHER DISLOCATION OF THE LINER FROM THE GLENOSPHERE AND THE CAUSE IS UNKNOWN. THE SURGEON UPSIZED THE GLENOSPHERE, LINER AND METAPHYSIS. THE SURGERY WAS SUCCESSFULLY COMPLETED.

  Patient problems: Joint Dislocation

  MAUDE report 23070939 ↗
• InjuryJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2025. ON (B)(6) 2025, 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. THE SURGERY WAS COMPLETED SUCCESSFULLY. (B)(4) WAS SENT. SUBSEQUENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE METAPHYSIS. THE SURGEON UPSIZED THE LINER AND (B)(4) WAS SENT. PRESENTLY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE METAPHYSIS, LINER, GLENOSPHERE, SCREWS, AND BASEPLATE. THE PATIENT WAS CONVERTED FROM A REVERSE SHOULDER TO A HEMI SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 22518250 ↗
• InjuryMar 12, 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 GLENOSPHERE FROM THE LINER AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 21585869 ↗
• InjuryOct 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION. THE SURGEON CONVERTED THE PATIENT FROM A REVERSE SHOULD TO A HEMIARTHROPLASTY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20383567 ↗
• InjuryJul 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY AT ABOUT 4 MONTHS FROM THE PRIMARY DUE TO JOINT LUXATION. THERE WERE PREVIOUS DISLOCATIONS WHICH HAVE BEEN TREATED MANUALLY. THE SURGEON REVISED METAPHYSIS, GLENOSPHERE AND LINER AND COMPLETED THE SURGERY SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19837127 ↗
• InjuryMay 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO SHOULDER LUXATION AT ABOUT 3 MONTHS AFTER PRIMARY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 19248900 ↗
• InjuryJan 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 3 MONTHS FROM 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: Joint Dislocation

  MAUDE report 18569377 ↗
• InjuryNov 14, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS OBSERVED THAT THE PATIENT WAS EXPERIENCING IMPINGEMENT OF THE GLENOSPHERE ON THE SCAPULA WITH SCAPULA NOTCHING. THE CAUSE OF THIS OCCURRENCE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME REPORTING PAIN DUE TO SHOULDER LUXATION AFTER LIFTING A HEAVY WEIGHT. THE SURGEON REMOVED THE GLENOSPHERE, LINER, METAPHYSIS, GLENOID BASEPLATE AND REPOSITIONED THE BASEPLATE MORE INFERIOR ON THE GLENOID. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 18128714 ↗
• InjuryOct 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT 1 MONTH AND A HALF FROM THE PRIMARY, 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.

  Patient problems: Joint Dislocation

  MAUDE report 17918325 ↗
• InjuryApr 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2022, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF THE INSTABILITY IS UNKNOWN. THE SURGEON REVISED SUCCESSFULLY THE INSERT. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED SUCCESSFULLY THE LINER AND GLENOSPHERE.

  Patient problems: Implant Pain

  MAUDE report 16722683 ↗
• InjuryDec 20, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE OF INSTABILITY IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN DUE TO ANTERIOR SUBLUXATION OF THE REVERSE REVISION COMPONENTS. THE SURGEON REVISED THE GLENOSPHERE, INSERT, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16015095 ↗
• InjuryJul 15, 2022Device Dislodged or Dislocated

  AT ABOUT 8 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE DISASSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. THE SURGEON REVISED THE GLENOSPHERE, SCREW AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Failure of Implant; Pain

  MAUDE report 15028118 ↗
• InjuryMay 5, 2022Migration or Expulsion of Device

  THE PATIENT CAME IN FOR A POST-OP APPOINTMENT AND IT WAS REVEALED THAT THE GLENOSPHERE ECCENTRICITY HAS SHIFTED SUPERIORLY. THE SURGEON PLANS TO REVISE THE PATIENT ON (B)(6) 2022. PRIMARY SURGERY WAS PERFORMED IN (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 14286985 ↗
• InjuryOct 25, 2021Adverse Event Without Identified Device or Use Problem

  ABOUT 3 MONTHS AFTER THE PRIMARY SURGERY THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT, REMOVED ALL COMPONENTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12688216 ↗
• InjuryOct 14, 2021Loose or Intermittent Connection; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  ON THE SECOND DAY AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER AND THE METAPHYSIS DUE TO INSTABILITY AND LOOSENESS (MDR 2021-00784). PRESENTLY, 3 WEEKS AFTER THE PREVIOUS SURGERY, THE PATIENT CAME IN DUE TO A DISLOCATION OF THE HUMERUS FROM THE GLENOSPHERE. THE SURGEON REVISED THE BASEPLATE, LATERALIZED GLENOSPHERE, HUMERAL DIAPHYSIS, REVERSE METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.)

  Patient problems: Joint Dislocation

  MAUDE report 12630782 ↗
• InjurySep 7, 2021Device Dislodged or Dislocated

  9 MONTHS AFTER THE PRIMARY SURGERY 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 GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 12432612 ↗
• InjuryMar 17, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING PAIN 1 MONTH AFTER THE PRIMARY SURGERY DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED ALL MEDACTA COMPONENTS WITH COMPETITOR COMPONENTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 11504339 ↗