Shoulder System 04.01.0190Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 07630040708098), received between Jun 21, 2019 and Jan 29, 2026 — classified as 12 injuries, 1 malfunction.

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. 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjuryJan 29, 2026Loss of Osseointegration

  AT ABOUT 8 MONTHS FROM PRIMARY THE PATIENT REPORTED INSTABILITY, DURING SURGERY, THE SURGEON OBSERVED THAT THE BASEPLATE WAS LOOSE. BONE QUALITY WAS NOT AN ISSUE. THE SURGEON REVISED THE BASEPLATE, LINER, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. BONE GRAFT WAS NOT USED DURING THE PRIMARY SURGERY AND 3 SCREWS WERE USED TO SECURE THE BASEPLATE.

  Patient problems: Aseptic loosening

  MAUDE report 24208584 ↗
• InjuryJan 8, 2026Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY AFTER 3 YEARS AND 10 MONTHS POST-PRIMARY DUE TO A LOOSE BASEPLATE. ALL COMPONENTS REVISED.

  Patient problems: Aseptic loosening

  MAUDE report 24004369 ↗
• InjuryNov 5, 2025Loss of Osseointegration; Loss of Osseointegration

  AT ABOUT 1 YEAR FROM PRIMARY, THE PATIENT CAME IN REPORTING PAIN. THE SURGEON, SUSPECTING IMPINGEMENT, REMOVED THE POLY, CUP AND GLENOSPHERE. UPON ATTEMPTING TO PLACE A NEW GLENOSPHERE, THE SURGEON NOTICED THE BASEPLATE WAS LOOSE. THE SURGEON DID NOT FIND ANY FRACTURES AND CAUSE OF LOOSINENG COULD NOT BE ESTABLISHED. THE SURGEON REVISED THE GLENOSPHERE, LINER, METAPHYSIS, AND BASEPLATE WITH MEDACTA IMPLANTS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Aseptic loosening

  MAUDE report 23478286 ↗
• InjuryOct 31, 2024Loss of Osseointegration; Loss of Osseointegration

  THE PATIENT HAD PAIN DUE TO A LOOSE BASEPLATE AND THE CAUSE IS UNKNOWN. AT ABOUT 3 YEARS AND 1 MONTH POST PRIMARY THE SURGEON REVISED THE HUMERAL TRAY, INSERT, BASEPLATE, GLENOSPHERE AND SCREWS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 20576912 ↗
• InjuryApr 4, 2024Malposition of Device; Malposition of Device

  AT ABOUT 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO THE MALALIGNMENT OF THE THREADED BASESPLATE. THERE WAS A LARGE INFERIOR OSTEOPHYTE IN THE NATIVE GLENOID THAT WAS NOT REMOVED, RESULTING IN THE GLENOID IMPLANT PLACED TOO LOW. THE SURGEON REVISED THE METAPHYSIS, LINER, GLENOSPHERE, AND BASEPLATE. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Pain

  MAUDE report 19040467 ↗
• InjuryMar 7, 2024Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  THE PATIENT CAME REPORTING PAIN. X-RAYS THAT WERE TAKEN SHOWED THAT THE ENTIRE GLENOID BUILD WAS LOOSE IN THE SHOULDER SPACE. GLENOSPHERE WAS IN PLACE AND ALL POLYAXIAL SCREWS WERE INTACT. ABOUT 1 YEAR AFTER THE PRIMARY SURGERY, THE SURGEON CONVERTED THE PATIENT TO A HEMI. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS BAD RHEUMATOID ARTHRITIS - BONE WAS IN BAD CONDITION. BONE GRAFT WAS NOT USED DURING THE PRIMARY SURGERY. NO TRAUMATIC EVENT REPORTED AND ALL GLENOID POLYAXIAL LOCKING SCREWS WERE INTACT.

  Patient problems: Pain

  MAUDE report 18854199 ↗
• InjuryFeb 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED AT ABOUT 2 YEARS AND 1 MONTH AFTER PRIMARY DUE TO SHOULDER LOOSENING. DURING THE PRIMARY SURGERY, THE BASEPLATE WAS POSITIONED SLIGHTLY SUPERIOR. THE SURGEON REVISED SUCCESSFULLY BASEPLATE, GLENOSPHERE, METAPHYSIS AND LINER.

  Patient problems: Joint Laxity

  MAUDE report 16435219 ↗
• InjuryFeb 10, 2023Malposition of Device; Malposition of Device

  THE PATIENT CAME IN REPORTING PAIN DUE TO A MALPOSITIONED BASEPLATE 5 MONTHS AFTER THE PRIMARY SURGERY. THE SURGEON REVISED THE BASEPLATE, POLY, GLENOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Implant Pain

  MAUDE report 16349595 ↗
• InjurySep 7, 2022Migration or Expulsion of Device; Migration or Expulsion of Device

  REVISION SURGERY PERFORMED 2 MONTHS AFTER THE PRIMARY DUE TO THREADED GLENOID BASEPLATE MOBILIZATION. THE SURGEON EXPLANTED THE BASEPLATE, SCREWS, GLENOSPHERE, PE LINER AND HUMERAL METAPHYSIS.

  Patient problems: Insufficient Information

  MAUDE report 15368480 ↗
• MalfunctionMay 25, 2022Naturally Worn

  THE PATIENT CAME IN REPORTING PAIN AND LIMITED MOTION. X-RAYS REVEALED THAT THE GLENOSPHERE DISASSOCIATED FROM THE GLENOID. AT 3 YEARS AND 4 MONTHS AFTER THE PRIMARY SURGERY, THE SURGEON REVISED THE BASEPLATE, LINER, GEOSPHERE AND METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY. THIS HAD OBVIOUSLY BEEN AN ISSUE FOR A LONG TIME. NOTICE THE AMOUNT OF METALLOSIS, BONE RESORPTION AND WEAR OF COMPONENTS. THE GLENOSPHERE WAS FLOATING IN THE JOINT. THERE WAS NO WEAR OR DAMAGE TO THE GLENOSPHERE SCREW.

  Patient problems: Metal Related Pathology

  MAUDE report 14494641 ↗
• InjuryAug 3, 2021Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  REVISION SURGERY PERFORMED 1 MONTH AFTER THE PRIMARY DUE TO THE BASEPLATE PULLING OUT OF THE BONE(THE PATIENT HAD POOR BONE QUALITY). THE SURGEON CONVERTED THE PATIENT FROM REVERSE TO ANATOMIC SYSTEM.

  Patient problems: Failure of Implant

  MAUDE report 12266745 ↗
• InjuryMay 19, 2021Appropriate Device Problem Term/Code Not Available

  11 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, PLACED ANTIBIOTICS, REMOVED THE GLENOSPHERE AND BASEPLATE AND CONVERTED THE HUMERAL COMPONENT TO A HEMI-SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Unspecified Infection

  MAUDE report 11848918 ↗
• InjuryJun 21, 2019Device Dislodged or Dislocated; Loosening of Implant Not Related to Bone-Ingrowth

  ABOUT 3 MONTHS AFTER PRIMARY THE ENTIRE GLENOID CONSTRUCT (BASEPLATE, SCREWS AND GLENOSPHERE) LOOSENED AND DISLOCATED AS A UNIT. GLENOSPHERE DISLOCATED FROM LINER. THE SURGEON PULLED THE ENTIRE CONSTRUCT OUT AS A UNIT (BASE PLATE WAS LOOSE FROM THE BONE). THE SURGEON REMOVED AND REPLACED THE SCREWS, THREADED BASEPLATE, HUMERAL LINER AND THE HUMERAL METAPHYSIS. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 8721214 ↗