Shoulder System 04.01.0207Recalls & reported problems

Summary

The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 07630040728065), received between Feb 7, 2022 and Sep 9, 2026 — classified as 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 16, 2026.

Most reported problems

Recent adverse event reports

The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Dislodged or Dislocated

  Revision surgery due to dislocation of the liner from the glenosphere after about 9 months from primary. The surgeon revised the D 36x24.5 glenosphere to a Lat. Glenosphere 36xD 24.5 and revised the reverse HC liner D 36/+0mm to a constrained E-CROSS liner D 36/+3.

  Patient problems: Joint Dislocation

  MAUDE report 50692293 ↗
• InjuryMay 12, 2026Adverse Event Without Identified Device or Use Problem

  AT ABOUT 7 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN PRESENTING PAIN AND INSTABILITY AND THE CAUSE IS UNKNOWN. THERE WERE NO INDICATIONS OF TRAUMA. THE SURGEON CONFIRMED NO GLENOID FRACTURE WAS PRESENT. THE SURGEON REVISED THE METAPHYSIS, GLENOSPHERE AND THE LINER D 36/+3MM TO A CONSTRAINED E-CROSS LINER D 39/+0. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 25148960 ↗
• InjuryApr 14, 2026Device Dislodged or Dislocated

  THE PATIENT CAME IN PRESENTING PAIN AFTER LIFTING A HEAVY OBJECT. X-RAYS REVEALED THAT THE GLENOSPHERE HAD DISASSOCIATED FROM THE BASEPLATE. ABOUT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON PERFORMED A REVISION SURGERY.DURING THE REVISION, IT WAS NOTED THAT THE INCORRECT SIZE COMBINATION WAS IMPLANTED AT THE PRIMARY SURGERY (GLENOSPHERE 24.5 WITH GLENOID BASEPLATE 22). IT IS UNCLEAR HOW THE ERROR WAS NOT NOTICED OR AVOIDED. THE ERROR WAS ONLY NOTED DURING THE REVISION SURGERY. THE SURGEON REVISED THE METAPHYSIS FROM A +0MM/0°; TO A +9MM/0°; SIZE, REVISED THE CONSTRAINED LINER TO A SAME SIZE NON-CONSTRAINED LINER, AND REVISED THE 36XD 24.5 GLENOSPHERE TO A SIZE D 36X22 GLENOSPHERE TO PROVIDE STABILITY WITH THE D 22X15 BASEPLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain; Joint Dislocation

  MAUDE report 24871717 ↗
• InjuryMar 30, 2026Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD PRIMARY ANATOMIC TOTAL LEFT SHOULDER SURGERY ON (B)(6) 2025. ON (B)(6) 2025, THE PATIENT CAME IN REPORTING PAIN AFTER FALLING AND SUSTAINING AN ACUTE SUBSCAPULAR FAILURE/DISLOCATION. THE SURGEON CONVERTED THE PATIENT FROM ANATOMIC TO REVERSE. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2026, THE PATIENT CAME IN PRESENTING ONGOING INSTABILITY AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE FROM A 36/LAT TO A 39/LAT, AND REVISED THE DIAPHYSIS, METAPHYSIS AND LINER TO A COMPETITOR DIAPHYSIS, METAPHYSIS AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 24710834 ↗
• InjuryJun 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 1 YEAR FROM PRIMARY, DURING POSTOP VISIT, THE SURGEON DETECTED AN ACROMION FRACTURE AND PRESCRIBED PHYSIOTHERAPY TO THE PATIENT. NO REVISION PLANNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 22209609 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CLINICAL STUDY, THE PATIENT HAD A CORACOID FRACTURE DUE TO EXCESSIVE LATERALIZATION OF THE PROSTHESIS DURING IMPLANTATION. THE PATIENT IS UNDERGOING PHYSIOTHERAPY AND IT IS UNDER SURVEILLANCE. IT HAS BEEN REPORTED THAT MY SHOULDER WAS USED IN THE PRIMARY. BONE QUALITY IS PRECARIOUS.

  Patient problems: Bone Fracture(s)

  MAUDE report 21354818 ↗
• InjuryJan 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  DURING A CLINICAL STUDY, AT ABOUT 10 MONTHS POST PRIMARY THE PATIENT HAS AN ACROMION FRACTURE DUE TO LATERALIZATION OF THE PROSTHESIS. NO REVISION PLANNED. THE PATIENT HAS AN INCOMPLETE SHOULDER ELEVATION.

  Patient problems: Bone Fracture(s)

  MAUDE report 21148421 ↗
• InjuryMar 22, 2024Migration; Migration

  AT ABOUT 1 YEAR 11 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE GLENOSPHERE AND THE CAUSE IS UNKNOWN. FROM THE X-RAYS A BROKEN SCREW CAN BE OBSERVED. THE SURGEON REVISED THE LINER, METAPHYSIS AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18959438 ↗
• InjuryApr 26, 2023Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 8 MONTHS AFTER THE PRIMARY SURGERY DUE TO GLENOSPHERE DISASSOCIATION FROM BASEPLATE (THE GLENOSPHERE SCREW WAS FOUND INTACT DURING THE REVISION). THREE POLYAXIAL LOCKING SCREWS WERE USED DURING THE PRIMARY SURGERY; DURING THE REVISION SURGERY, THE SURGEON NOTED THAT THE LOCKING SCREWS WERE NOT LOCKED. THE SURGEON REVISED THE METAPHYSIS, LINER AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY. IT IS UNKNOWN IF THE GLENOSPHERE GUIDE WAS USED DURING THE PRIMARY SURGERY.

  Patient problems: Pain

  MAUDE report 16813632 ↗
• InjuryApr 12, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 MONTH AND 2 WEEKS AFTER THE PRIMARY SURGERY, THE SURGEON DECIDED TO REVISE THE INLAY AND THE GLENOSPHERE DUE TO A POSSIBLE INFECTION. A NEW GLENOSPHERE (36MM LATERALIZED) AND INLAY (36/0MM) WERE IMPLANTED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 16723119 ↗
• InjuryMar 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD PRIMARY HIP SURGERY ON (B)(6) 2021. AT ABOUT 4 WEEKS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A PERIPROSTHETIC FRACTURE THAT WAS CAUSED BY FALLING. THE SURGEON PLATED THE FRACTURE AND DID NOT REVISE ANY IMPLANTS. PRESENTLY, ON (B)(6) 2022, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON RE-PLATED THE FRACTURE AND EXCHANGED THE HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON OBSERVED SUBLUXATION. THE SURGEON DECIDED TO REVISE THE MEDACTA HEAD AND SLEEVE TO A NEW MEDACTA HEAD AND SLEEVE AND THE MEDACTA CUP AND LINER TO A COMPETITOR CUP AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 16501463 ↗
• InjuryMar 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, REVISION SURGERY DUE TO SHOULDER LUXATION. THE SURGEON REVISED SUCCESSFULLY THE GLENOSPHERE, LINER, METAPHYSIS AND DIAPHYSIS.

  Patient problems: Insufficient Information

  MAUDE report 16501462 ↗
• InjuryDec 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY DUE TO LAXITY. AT ABOUT 1 YEAR AND 2 MONTHS POST PRIMARY THE SURGEON REVISED THE 36XØ24.5MM GLENOSPHERE WITH A 39XØ24.5MM GLENOSPHERE, REVISED THE Ø36/+3MM LINER WITH A Ø39/+0MM AND REVISED THE +0MM/0° METAPHYSIS WITH A +9MM/0° METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 15994321 ↗
• InjurySep 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE LINER FROM THE GLENOSPHERE 2 MONTHS AFTER THE PRIMARY THAT WAS SUSTAINED WHILE THE PATIENT WAS SLEEPING. THE SURGEON REVISED THE GLENOSPHERE AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 15400693 ↗
• InjuryJun 17, 2022Unstable; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN REPORTING INSTABILITY AND LOOSENESS AND THE CAUSE IS UNKNOWN. AT 2 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE LATERALIZED GLENOSPHERE, METAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

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

  MAUDE report 14733623 ↗
• InjuryMay 10, 2022Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE WAS UNKNOWN. AT 3 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE GLENOSPHERE, LINER, AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 14346257 ↗
• InjuryFeb 7, 2022Unstable

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

  Patient problems: Joint Laxity

  MAUDE report 13470948 ↗