Shoulder System 04.01.0121Recalls & reported problems

Summary

The FDA's MAUDE database contains 28 adverse event reports that list this exact device (DI 07630040706285), received between Apr 25, 2019 and Jul 8, 2026 — classified as 28 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (15 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 28 reports, in the reporter's own words as published by the FDA.

• InjuryJul 8, 2026Device Dislodged or Dislocated

  REVISION SURGERY DUE TO JOINT LUXATION BETWEEN LINER AND GLENOSPHERE AFTER ABOUT 2 MONTHS FROM FIRST REVISION SURGERY.THE PATIENT HAD PRIMARY RIGHT REVERSE SHOULDER SURGERY ON (B)(6) 2023.THE SURGEON REVISED THE LINER TO A CONSTRAINED AND THE REVERSE METAPHYSIS.

  Patient problems: Joint Dislocation

  MAUDE report 25747748 ↗
• InjuryMay 15, 2026Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS FROM THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AS A RESULT OF A DISLOCATION OF THE GLENOSPHERE AND LINER AND THE CAUSE IS UNKNOWN. THERE WAS NO REPORTS OF TRAUMA. THE SURGEON BELIEVED THAT THE IMPLANT HAD BEEN OVERSTUFFED AND THAT THIS MAY HAVE CAUSED THE DISLOCATION. THE LINER WAS REVISED FROM AN HC LINER D 36/+6 MM TO AN HC LINER D 36/+3 MM. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 25185353 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  AT 7 MONTHSFROM PRIMARY, THE PATIENT CAME IN PRESENTING SHOULDER PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. DURING OPEN EXPLORATION SURGERY, THE SURGEON OBSERVED THAT THE GLENOSPHERE WAS UNSTABLE. THE SURGEON REVISED THE GLENOSPHERE AND INCREASED LATERALIZATION TO INCREASE STABILITY. THE SURGEON ALSO REVISED THE D 36/+6 LINER TO A CONSTRAINED LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 25012260 ↗
• InjuryMar 12, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN DURING ROTATION AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 24579145 ↗
• InjuryJan 29, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY WAS PERFORMED THREE MONTHS AFTER THE PRIMARY PROCEDURE DUE TO SHOULDER MICRO-INSTABILITY AND SUBLUXATION CAUSING PAIN; THE ROOT CAUSE COULD NOT BE DETERMINED. THE SURGEON REVISED THE REVERSE LINER, REPLACING IT WITH A CONSTRAINED LINER OF THE SAME SIZE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 24208583 ↗
• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23836931 ↗
• InjuryNov 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT INITIALLY UNDERWENT PRIMARY SHOULDER SURGERY USING A COMPETITOR & RSQUO, S PRODUCTS. ON (B)(6) 2025, A REVISION WAS PERFORMED WITH MEDACTA IMPLANTS. ON (B)(6), 2025, THE PATIENT PRESENTED WITH PAIN DUE TO A DISLOCATION OF UNKNOWN CAUSE. REVISION SURGERY WAS PERFORMED TO ENLARGE THE GLENOSPHERE, METAPHYSIS, AND LINER TO ENHANCE JOINT STABILITY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 23510653 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 3 MONTHS FROM PRIMARY THE PATIENT REPORTED PAIN AND INSTABILITY, THE SURGEON REVISED THE REVERSE SHOULDER TO AN HEMI. SURGERY COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Laxity

  MAUDE report 22902790 ↗
• InjuryAug 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER 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. SURGEON DID NOT REVISE GLENOSPHERE BECAUSE IT WAS WELL FIXED. SURGEON REVISED THE METAPHYSIS BECAUSE HE WANTED TO ADD HUMERAL HEIGHT TO INCREASE STABILITY AND PREVENT A RECURRENT DISLOCATION.

  Patient problems: Implant Pain

  MAUDE report 22892576 ↗
• InjuryFeb 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2019. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A FAILED ANATOMIC SHOULDER AFTER FALLING. THE SURGEON CONVERTED THE PATIENT TO A REVERSE SHOULDER AND THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION AFTER MOVING FURNITURE. THE EFFORT IS REPORTED TO BE A NORMAL ONE, NOT ANYTHING RISKY. THE SURGEON REVISED THE METAPHYSIS, GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 21330821 ↗
• InjuryJan 24, 2025Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTHS FROM 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 21227336 ↗
• InjuryNov 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 4 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. THE SURGEON REVISED THE LINER AND THE METAPHYSIS AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20628413 ↗
• InjuryNov 6, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE. ABOUT 3 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20618943 ↗
• InjurySep 17, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A PRIMARY (B)(6) 2019. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE GLENOID COMPONENT. THE CAUSE OF THE LOOSE GLENOID COMPONENT IS UNKNOWN. THE SURGEON REVISED THE GLENOID, GLENOSPHERE, METAPHYSIS AND LINER. 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 BASEPLATE, GLENOSPHERE, SCREWS, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20237365 ↗
• InjurySep 16, 2024Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. ABOUT 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A WASHOUT AND REVISED THE LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 20224274 ↗
• InjuryJun 24, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FOR THE GLENOSPHERE. THE SURGEON REVISED AUCCESSFULLY THE GLENOSPHERE, LINER, AND METAPHYSIS.

  Patient problems: Implant Pain

  MAUDE report 19593163 ↗
• InjuryMar 7, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY DUE TO SHOULDER DISLOCATION AND THE CAUSE IS UNKNOWN. AT 3 DAYS FROM PRIMARY, THE SURGEON REVISED THE METAPHYSIS AND LINER. A THICKER METAPHYSIS HAS BEEN IMPLANTED TO MAKE THE SHOULDER TIGHTER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18854201 ↗
• InjuryJan 16, 2024Migration; Migration

  REVISION SURGERY FOR SHOULDER SUB-LUXATION 5 MONTHS POST PRIMARY. LINER, GLENOSPHERE AND METAPHYSIS REVISED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 18517260 ↗
• InjuryNov 30, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED SUCCESSFULLY THE LINER.

  Patient problems: Unspecified Infection

  MAUDE report 18237289 ↗
• InjuryFeb 3, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON PERFORMED A WASHOUT AND REVISED THE POLY, STEM, AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16291932 ↗
• InjuryDec 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED AT ABOUT 13 DAYS AFTER THE PRIMARY DUE TO JOINT DISLOCATION. THE SURGEON REVISED SUCCESSFULLY THE LINER. DIAPHYSIS AND METAPHYSIS WERE REVISED TO GIVE PATIENT MORE STABILITY.

  Patient problems: Pain

  MAUDE report 15995222 ↗
• InjuryNov 10, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION AND THE CAUSE OF THE DISLOCATION IS UNKNOWN. THE SURGEON REVISED THE METAPHYSIS AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15770502 ↗
• InjuryJul 1, 2022Device Dislodged or Dislocated

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT RETURNED FOR THE CONTROL RX WITH NO PAIN OR SYMPTOMS. DISLOCATION OF THE LINER FROM THE GLENOSPHERE WAS DETECTED ONLY AFTER X-RAYS. THE REVISION SURGERY WAS PERFORMED AND THE SURGEON REVISED SUCCESSFULLY THE GLENOSPHERE AND INSERT (Ø36 TO Ø39).

  Patient problems: Joint Dislocation

  MAUDE report 14885611 ↗
• InjuryFeb 17, 2021Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 1 MONTH AFTER THE PREVIOUS REVISION SURGERY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL HARDWARE AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PREVIOUS REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION( GLENOSPHERE AND LINER REVISED). THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2020.

  Patient problems: Unspecified Infection

  MAUDE report 11337935 ↗
• InjuryJan 5, 2021Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED ON (B)(6) 2020 DUE TO RECURRENT SHOULDER DISLOCATION (GLENOSPHERE AND INLAY HAVE BEEN REVISED) 3 MONTHS AFTER THE PRIMARY SURGERY((B)(6) 2020). THE PATIENT WAS ALREADY REVISED, AT THE BEGINNING OF (B)(6) 2020, WHERE THE INLAY HAS BEEN CHANGED FROM Ø36/+0MM TO Ø36/+6MM.

  Patient problems: Joint Dislocation

  MAUDE report 11116243 ↗