Shoulder System 04.01.0191Recalls & reported problems

Summary

The FDA's MAUDE database contains 16 adverse event reports that list this exact device (DI 07630040715478), received between Apr 27, 2018 and Mar 31, 2026 — classified as 16 injuries.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (3 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 16 most recent of 16 reports, in the reporter's own words as published by the FDA.

• InjuryMar 31, 2026Osseointegration Problem

  ON (B)(6) 2026, ABOUT 3 YEARS AFTER THE PREVIOUS REVISION SURGERY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE BASEPLATE (SECURED WITH 4 SCREWS) DUE TO POOR BONE QUALITY. THE SURGEON REVISED THE THREADED BASEPLATE TO A GRS BASEPLATE, REVISED THE D 36X24.5 GLENOSPHERE TO A D 42X24.5 GLENOSPHERE, AND THE D 36/+3 REVERSE LINER TO A D 42/+6MM LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY. BONE GRAFT WAS NOT USED DURING PRIMARY AND FIRST REVISION. THE PATIENT HAD PRIMARY RIGHT SHOULDER SURGERY ON (B)(6) 2022. ON (B)(6) 2023, THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED BASEPLATE AND THE CAUSE OF THE MALPOSITIONED BASEPLATE IS UNKNOWN. THE SURGEON REVISED THE BASEPLATE, GLENOSPHERE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 24738821 ↗
• InjuryOct 16, 2025Fracture; Loosening of Implant Not Related to Bone-Ingrowth; Fracture; Loosening of Implant Not Related to Bone-Ingrowth

  THE DIAPHYSIS SHOW RADIOLUCENT LINES THE SURGEON SAID IT WAS KIND OF LOOSE AND WAS CAUSING PAIN WHEN THE PATIENT MOVED. THE BASEPLATE IS LOOSE TOO. IN THE X-RAYS A BROKEN SCREW IS VISIBLE BUT THE REASON IS UNKNOWN. AT ABOUT 2 YEARS AND 4 MONTHS POST-PRIMARY THE SURGEON REVISED THE LINER AND METAPHYSIS WITH MEDACTA PRODUCT AND REVISED THE BASEPLATE WITH A COMPETITOR PRODUCT. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening; Implant Pain

  MAUDE report 23309927 ↗
• InjuryNov 27, 2024Failure to Osseointegrate; Failure to Osseointegrate

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2024. ON (B)(6) 2024, 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. ON (B)(6) 2024 THE PATIENT CAME IN REPORTING PAIN DUE TO THE BASEPLATE DISLODGING FROM THE GLENOID. NO BONE GRAFT USED IN THE PREVIOUS SURGERIES. THE SURGEON CONVERTED THE PATIENT TO A REVERSE TO A HEMI. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20794756 ↗
• InjuryAug 9, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT ABOUT 2 YEARS AND 6 MONTHS AFTER PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO INSTABILITY OF THE GLENOID AND THE CAUSE IS UNKNOWN. MOREOVER, THERE WAS EVIDENCE OF RADIOLUCENCY AROUND THE PERIPHERAL SCREWS AND CENTRAL SCREW. THE SURGEON REVISED THE GLENOSPHERE, SCREWS, BASEPLATE, POLY AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE LINER AND METAPHYSIS HAD TO BE REMOVED IN ORDER TO HAVE ACCESS TO THE GLENOSPHERE AND BASEPLATE.

  Patient problems: Implant Pain

  MAUDE report 19947300 ↗
• InjuryMar 20, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  AT ABOUT 4 YEARS 4 MONTHS AFTER THE PRIMARY, 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.

  Patient problems: Pain

  MAUDE report 18941960 ↗
• InjuryDec 19, 2023Positioning Problem; Positioning Problem

  AT ABOUT 2 YEARS FROM THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND THE SURGEON DETERMINED THE BASEPLATE AND GLENOSPHERE WERE POSITIONED TOO SUPERIOR OF THE GLENOID. THE SURGEON REVISED THE GLENOSPHERE, BASEPLATE AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 18354880 ↗
• InjuryMay 5, 2023Malposition of Device; Malposition of Device

  THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED BASEPLATE AND GLENOSPHERE (TILTED SUPERIOR) AND THE CAUSE IS UNKNOWN. ABOUT 1 YEAR AND 7 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE MEDACTA METAPHYSIS, BASEPLATE, SCREWS AND GLENOSPHERE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 16874674 ↗
• InjuryMar 10, 2023Malposition of Device; Malposition of Device

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

  Patient problems: Pain

  MAUDE report 16520983 ↗
• InjuryMay 7, 2022Material Separation

  REVISION SURGERY AT 3 YEARS AND 2 MONTHS POST PRIMARY DUE TO DISSOCIATION OF THE GLENOSPHERE FROM THE BASEPLATE. ALL DEVICES REVISED SUCCESSFULLY.

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

  MAUDE report 14317038 ↗
• InjuryMar 25, 2022Loosening of Implant Not Related to Bone-Ingrowth

  AT 7 MONTHS FROM PRIMARY SURGERY THE SURGEON REVISED ALL THE SHOULDER COMPONENTS FOR GLENOID BASEPLATE LOOSENING.

  Patient problems: Insufficient Information

  MAUDE report 13904001 ↗
• InjuryNov 23, 2021Appropriate Device Problem Term/Code Not Available

  AT 4 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 12860794 ↗
• InjuryNov 9, 2021Loose or Intermittent Connection; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  THE PATIENT HAD A PRIMARY SHOULDER SURGERY ON (B)(6) 2021. ON (B)(6) 2021, THE PATIENT CAME IN REPORTING INSTABILITY AND LOOSENESS AND THE CAUSE WAS UNKNOWN. THE SURGEON REVISED THE LINER AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. COMPLAINT (B)(4) WAS FILED. SUBSEQUENTLY, ON (B)(6) 2021, 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. COMPLAINT (B)(4) WAS FILED. PRESENTLY, ON (B)(6) 2021, THE PATIENT CAME IN DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 12779042 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem

  THE PATIENT CAME IN DUE TO SIGNS OF INFECTION AND THE PATHOGEN HAS BEEN IDENTIFIED AS ENTEROCOCCUS FAECALIS. THE SURGEON PERFORMED A WASHOUT, REVISED ALL IMPLANTS, AND PLACED A TEMPORARY ANTIBIOTIC SPACER, 4 MONTHS AFTER THE PRIMARY. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bacterial Infection

  MAUDE report 11162448 ↗
• InjuryDec 20, 2020Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY 2 WEEKS AFTER PRIMARY SURGERY FOR BASEPLATE MOBILIZATION FROM THE BONE. THE PATIENT HAS DEMENTIA. ALL COMPONENTS HAVE BEEN REVISED.

  Patient problems: Insufficient Information

  MAUDE report 11043168 ↗
• InjuryNov 26, 2019Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AFTER 3 MONTHS FROM THE PRIMARY DUE TO SIGNS OF AN INFECTION AND THE PATHOGEN IS UNKNOWN. THE SURGEON REMOVED ALL IMPLANTS AND IMPLANTED AN ANTIBIOTIC SPACER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 9375797 ↗
• InjuryApr 27, 2018Appropriate Device Problem Term/Code Not Available

  THE SALES REPRESENTATIVE HAS BEEN INFORMED BY THE SURGEON ON (B)(6) 2018 THAT A REVISION SURGERY WILL BE NECESSARY. REVISION SURGERY PERFORMED ON (B)(6) 2018 DUE TO CONSISTENT PAIN AFTER ABOUT 7 MONTHS FROM THE PRIMARY. METAPHYSIS, SCREWS, GLENOSPHERE AND BASEPLATE WERE REVISED. AFTER GLENOID POLYAXIAL SCREWS REMOVAL THE THREADED GLENOID BASEPLATE WAS TAKING OUT VERY EASILY.

  Patient problems: Joint Disorder

  MAUDE report 7468345 ↗