Shoulder System 04.01.0170Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 07630040706575), received between May 18, 2018 and Sep 9, 2026 — classified as 19 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 9, 2026Device Dislodged or Dislocated

  Revision surgery due to a dislocation of the liner and glenosphere after about 2 years and 3 months from primary. The surgeon revised the +0mm/0° metaphysis to a same size metaphysis, revised the D 39/+3mm reverse liner to a D 42/+0 constrained liner, and revised the D 39x24.5 glenosphere to a 42xD 24.5 lat. glenosphere.

  Patient problems: Joint Dislocation

  MAUDE report 50692305 ↗
• InjuryApr 28, 2026Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY AFTER 11 DAYS FROM PRIMARY DUE TO INFECTION. THE PATIENT PRESENTED TO THE EMERGENCY DEPARTMENT WITH URINARY RETENTION REQUIRING RECATHETERIZATION ATTEMPTS AND WAS DIAGNOSED WITH A URINARY TRACT INFECTION. ASPIRATION FROM THE SHOULDER WOUND SITE IDENTIFIED MORGANELLA MORGANII. A WASHOUT PROCEDURE WITH EXCHANGE OF THE LINER AND GLENOSPHERE USING THE SAME SIZE COMPONENTS WAS PERFORMED. IMPLANTS WERE NOTED TO BE WELL POSITIONED AND UNREMARKABLE.

  Patient problems: Medical device site infection

  MAUDE report 25012958 ↗
• InjuryAug 6, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN REPORTING INSTABILITY AND THE CAUSE IS UNKNOWN. ABOUT 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE HUMERAL REVERSE LINER, REVERSE METAPHYSIS AND LATERAL GLENOSPHERE. HE DECIDED TO INCREASE THE GLENOSPHERE SIZE, THE OFFSET OF THE METAPHYSIS, AND THE LINER SIZE TO IMPROVE THE STABILITY.

  Patient problems: Joint Laxity

  MAUDE report 22726919 ↗
• InjuryMar 17, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  ACROMION BONE FRACTURE HAS BEEN DETECTED POST-OPERATIVELY IN THE PATIENT AND THE CAUSE IS UNKNOWN. PHYSIOTHERAPY HAS BEEN PRESCRIBED AND REVISION SURGERY IS NOT PLANNED.

  Patient problems: Bone Fracture(s)

  MAUDE report 21618134 ↗
• MalfunctionJan 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2018 THE PATIENT HAD A PRIMARY ANATOMIC SHOULDER SURGERY. ON (B)(6) 2024, THE SURGEON CONVERTED THE PATIENT FROM AN ANATOMICAL SHOULDER TO A REVERSE SHOULDER DUE TO THE PATIENT REPORTING PAIN RELATED TO A ROTATOR CUFF FAILURE. ON (B)(6) 2024, THE PATIENT CAME IN REPORTING PAIN DUE TO A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE SURGEON CLOSED REDUCED UNDER ANESTHESIA THE PATIENT AND NO IMPLANTS WERE REVISED. THE CASE WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 21167796 ↗
• InjuryJan 16, 2025Device Dislodged or Dislocated; Migration; Device Dislodged or Dislocated; Migration

  AT ABOUT 4 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND FROM THE PERFORMED X-RAYS IT HAS BEEN NOTICED THAT THE GLENOSPHERE DISSOCIATED FROM THE BASEPLATE AND GLENOSPHERE SCREW UNSCREWED. ON THE POST-PRIMARY RADIOGRAPHS, A SLIGHT GAP CAN BE SEEN BETWEEN THE TIP OF THE GLENOID SCREW AND THE BASEPLATE PEG. MOREOVER, METALLOSIS WAS FOUND DURING REVISION SURGERY. A NEW GLENOSPHERE, GLENOSPHERE SCREW AND INLAY HAVE BEEN SUCCESSFULLY IMPLANTED.

  Patient problems: Implant Pain

  MAUDE report 21165846 ↗
• InjuryAug 21, 2024Device 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. ALL COMPONENTS REVISED SUCCESSFULLY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 20022350 ↗
• InjuryAug 6, 2024Migration; Migration

  DURING A CONTROL VISIT IT WAS FOUND THAT THE GLENOSPHERE WAS DISENGAGED FROM THE BASEPLATE. REVISION SURGERY WAS PERFORMED AT ABOUT 1 YEAR AND 4 MONTHS POST-PRIMARY. ALL DEVICES WERE REVISED SUCCESSFULLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19918233 ↗
• InjuryJun 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PRIMARY SURGERY (B)(6) 2023 AFTER A TONIC CLONIC SEIZURE WITH POSTERIOR LUXATIONS ON BOTH THE LEFT AND RIGHT SHOULDER. BONE GRAFTS USED. 1ST REVISION SURGERY PERFORMED (B)(6) 2024 AFTER RECURRENT SHOULDER LUXATIONS ON THE RIGHT SIDE AND GLENOID BASEPLATE LOOSENING. CHANGE OF BASEPLATE, SCREWS, GLENOSPHERE AND LINER. HUMERAL DIAPHYSIS AND METAPHYSIS STAY IN SITU. 2ND REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 AFTER PERSISTENT SHOULDER LUXATIONS. CHANGE OF GLENOSPHERE AND LINER. BASEPLATE, HUMERAL DIAPHYSIS AND METAPHYSIS STAY IN SITU.

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

  MAUDE report 19632759 ↗
• InjuryMar 3, 2023Migration; Migration

  ON (B)(6) 2022, THE PATIENT HAD A PRIMARY SHOULDER SURGERY AND MEDACTA REVERSE SHOULDER SYSTEM WAS IMPLANTED. PRESENTLY, ON (B)(6) 2023, THE PATIENT WAS REVISED DUE TO JOINT LUXATION. DURING REVISION SURGERY, THE SURGEON NOTICED THAT THE SCREW OF THE GLENOSPHERE WAS LOOSE AND THAT THERE WAS A VERY FEW FIXATION ON THE TAPER. THE SURGERY WAS COMPLETED SUCCESSFULLY BY USING ANOTHER GLENOSPHERE, SCREW AND LINER.

  Patient problems: Joint Dislocation

  MAUDE report 16476398 ↗
• InjuryFeb 7, 2022Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

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

  Patient problems: Joint Dislocation

  MAUDE report 13469562 ↗
• InjuryDec 14, 2021Unstable; Unstable

  AT 9 MONTHS AND HALF AFTER THE PRIMARY, 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. THE SURGEON REVISED THE GLENOSPHERE BECAUSE HE WANTED TO LATERALIZE THE COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 13001581 ↗
• InjuryNov 9, 2021Material Rupture; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD PRIMARY SHOULDER SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING PAIN DUE TO A RUPTURED SUBSCAP AND THE CAUSE IS UNKNOWN. THE SURGEON REVISED THE HUMERAL HEAD, PROXIMAL BODY, GLENOID. THE SURGERY WAS COMPLETED SUCCESSFULLY. PRESENTLY, ON (B)(6) 2021, 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 AND LINER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Dislocation

  MAUDE report 12777447 ↗
• InjurySep 28, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  REVISION SURGERY 1 YEAR AND 5 MONTHS AFTER PRIMARY DUE TO INTRA-PROSTHETIC DISLOCATION OF THE GLENOSPHRE FROM THE BASEPLATE. THE SCREW WAS LOOSE BUT IT WAS NOT OUT OF THE GLENOSPHERE. DURING THE REVISION THE BASE PLATE WAS 100% TIGHT AND BOTH SCREWS WERE FULLY COUNTERSUNK AND NOT LOOKING OUT EITHER. THE SURGEON INSERTED A NEW GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Insufficient Information

  MAUDE report 12538971 ↗
• InjuryMar 11, 2021Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN 1 MONTH AFTER THE PRIMARY SURGERY. X-RAYS INDICATED THAT THE PATIENT HAD A DISLOCATION OF THE GLENOSPHERE FROM THE LINER. THE SURGEON PLACED THE PATIENT UNDER ANESTHESIA AND REDUCED THE SHOULDER, AND THE SHOULDER SEEMED STABLE AFTERWARD.

  Patient problems: Joint Dislocation

  MAUDE report 11462145 ↗
• InjuryFeb 16, 2021Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME IN 4 MONTHS AFTER THE PRIMARY SURGERY REPORTING INSTABILITY DUE TO LAXITY. THE CAUSE OF THE LAXITY IS UNKNOWN. THE SURGEON REVISED THE GLENOSPHERE - Ø39X24.5 WITH A LATERALIZED GLENOSPHERE 39XØ24.5, AND REVISED THE HUMERAL REVERSE HC LINER Ø39/+6MM WITH A HUMERAL REVERSE HC LINER Ø39/+6MM 4 MONTHS AFTER PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Joint Laxity

  MAUDE report 11331837 ↗
• InjuryJan 12, 2021Appropriate Device Problem Term/Code Not Available

  SECOND REVISION SURGERY DUE TO SHOULDER LUXATION (INSTABILITY) OF THE GLENOSPHERE FROM THE LINER, 1 MONTH AFTER THE PREVIOUS OPERATION. DURING THE REVISION SURGERY THE METAPHYSIS, GLENOSPHERE AND LINER WERE REVISED. THE NEW GLENOSPHERE IS LATERALIZED AND THE LINER IS +3MM.

  Patient problems: Joint Dislocation

  MAUDE report 11153954 ↗
• InjuryMay 27, 2020Device Dislodged or Dislocated

  THE PATIENT CAME IN REPORTING PAIN DUE TO A FALL 1 YEAR AFTER THE PRIMARY SURGERY. THE LINER IS WORN, THE GLENOSPHERE DISSOCIATED FROM THE BASEPLATE AND THE SCREW UNSCREWED. THE SURGEON REVISED THE GLENOSPHERE, LINER, METAPHYSIS AND LEFT THE BASEPLATE IN PLACE AS IT WAS WELL FIXED, AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Fall; Pain

  MAUDE report 10091539 ↗
• InjuryOct 10, 2018Device Dislodged or Dislocated

  REVISION SURGERY PERFORMED 2 MONTHS AFTER PRIMARY SURGERY DUE TO LUXATION. HUMERUS DISLOCATED FROM GLENOSHERE.

  Patient problems: Joint Dislocation

  MAUDE report 7951005 ↗
• InjuryMay 18, 2018Device Dislodged or Dislocated

  ABOUT 2 MONTHS AFTER PRIMARY THE SURGEON REVISED THE PATIENT FOR A SHOULDER LUXATION. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: No Information

  MAUDE report 7525809 ↗