Shoulder System 04.01.0148Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07630040706353), received between May 19, 2020 and Oct 16, 2024 — classified as 4 injuries.

The most frequently reported specific device problem is “Failure to Osseointegrate” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryOct 16, 2024Failure to Osseointegrate; Failure to Osseointegrate

  AT ABOUT 1 MONTH AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE GLENOID BASEPLATE. THE CAUSE OF THE LOOSE GLENOID BASEPLATE IS UNKNOWN. THE SURGEON CONVERTED THE PATIENT TO AN ANATOMIC SHOULDER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 20459397 ↗
• InjuryOct 18, 2023Positioning Failure; Positioning Failure

  DURING THE PRIMARY SHOULDER SURGERY, IT WAS OBSERVED THAT THE SURGEON WAS NOT ABLE TO SET THE GLENOID ONTO THE BASEPLATE TWICE. THE LOCKING SCREW WOULD NOT SCREW INTO GLENOID BASEPLATE Ø22X15; A NEW LOCKING SCREW WAS OPENED BECAUSE THE ONE WITH THE GLENOSPHERE WAS DAMAGED BUT THE COUPLING WAS STILL NOT POSSIBLE. THE SURGEON CHANGED THE BASEPLATE TO A THREADED GLENOID BASEPLATE Ø24.5X25 AND AGAIN THE LOCKING SCREW WOULD NOT ENGAGE THE BASEPLATE. THE SURGEON SWITCHED TO A LAT. GLENOSPHERE 36XØ24.5, CHANGED THE POLY AND THE SURGERY WAS COMPLETED SUCCESSFULLY. THERE WAS A 2-HOUR DELAY. A CONSIGNMENT SET WAS UTILIZED. ADDITIONAL ANESTHESIA WAS ADMINISTERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17957400 ↗
• InjuryOct 8, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE PRIMARY SURGERY WAS PERFORMED ON (B)(6) 2021 AND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021. DUE TO SUSPICION OF HEMATOMA, THE SURGEON TOOK A CT SCAN AND NOTICED AN ABNORMALITY IN THE GLENOID FOSSA. DURING THE COURSE OF REVISION SURGERY, THE SURGEON NOTICED GLENOID FRACTURE AND DISLOCATION OF THE BASE PLATE. GLENOID IMPLANTS WERE ALL REMOVED. THE HUMERAL LINER AND TRAY WERE REPLACED WITH AN ANATOMICAL HEAD. THE SURGERY WAS COMPLETED SUCCESSFULLY. THE PATIENT HAS DEMENTIA, IT IS UNKNOWN IF THERE WAS A TRAUMATIC EVENT.

  Patient problems: Bone Fracture(s); Joint Dislocation

  MAUDE report 12597642 ↗
• InjuryMay 19, 2020Appropriate Device Problem Term/Code Not Available

  THE PATIENT CAME IN 2 YEARS AND 3 MONTHS AFTER 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 10069378 ↗