Shoulder System 04.01.0183Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 07630040715911), received between Sep 4, 2020 and Apr 2, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Appears to Trigger Rejection” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION SURGERY WAS PERFORMED AT 2 YEARS AND 2 MONTHS FROM THE PRIMARY SURGERY DUE TO DISLOCATION OF THE HUMERAL HEAD FROM THE GLENOID. INTRAOPERATIVELY, IT WAS DETERMINED THAT THE PATIENT'S HUMERUS WAS FRACTURED AND THE SURGEON OPTED TO USE A FRACTURE STEM FROM EXACTECH TO COMPLETE THE CASE. THE SURGEON CONVERTED THE PATIENT FROM AN ANATOMIC SHOULDER TO A REVERSE SHOULDER AND THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Bone Fracture(s)

  MAUDE report 19018506 ↗
• InjuryJul 27, 2023Device Appears to Trigger Rejection; Device Appears to Trigger Rejection

  AT ABOUT 1 YEAR AND 2 MONTHS AFTER THE PRIMARY, THE PATIENT CAME IN REPORTING PAIN AND RESULTED POSITIVE FOR CURTIBACTERIUM ACNES. THE SURGEON PERFORMED AN ANALGESIC TREATMENT AND REMOVED ALL THE IMPLANTS. THE PATIENT IS UNDER MONITORING.

  Patient problems: Medical device site infection

  MAUDE report 17404478 ↗
• InjuryNov 25, 2022Osseointegration Problem; Osseointegration Problem

  THE PATIENT CAME IN REPORTING PAIN DUE TO A LOOSE SHORT STEM AND THE CAUSE IS UNKNOWN. AT ABOUT 11 MONTHS FROM PRIMARY THE SURGEON REVISED THE METAPHYSIS, DIAPHYSIS, AND LINER. THE SURGERY WAS COMPLETED SUCCESSFULLY.

  Patient problems: Inadequate Osseointegration

  MAUDE report 15864356 ↗
• InjuryOct 6, 2022Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  DIRECTLY AFTER THE PRIMARY SHOULDER SURGERY, WHEN THE PATIENT WAS IN POST-OP RECOVERY, IT WAS OBSERVED THAT THE TIP OF THE SHORT STEM BROKE THROUGH THE LATERAL CORTEX. IT HAS BEEN REPORTED THAT THE PATIENT HAD INCREDIBLY HARD BONE AND IT WAS DIFFICULT TO INSERT THE STEM. THE REVISION SURGERY WAS COMPLETED SUCCESSFULLY EXPLANTING THE POLY, STEM, AND METAPHYSIS WHILE A STANDARD LENGTH STEM, +9 METAPHYSIS AND A PLUS 3 POLY WERE IMPLANTED.

  Patient problems: Bone Fracture(s)

  MAUDE report 15550761 ↗
• InjurySep 4, 2020Loose or Intermittent Connection

  REVISION SURGERY PERFORMED DUE TO DISLOCATION CAUSED BY STEM SUBSIDENCE ONE MONTH AFTER THE PRIMARY SURGERY. PROBABLY THE STEM WAS INSERTED A BIT TOO DEEPLY DURING THE PRIMARY SURGERY AND ALSO SUBSIDED AFTER THE PRIMARY SURGERY, WHAT CAUSED THAT THE STEM WAS FINALLY 3MM BELOW RESPECT TO THE PLANNED POSITION. THE LINER +0MM WAS REVISED WITH +3MM.

  Patient problems: Joint Disorder

  MAUDE report 10493615 ↗