SMR Metal Back Uncemented Glenoid (REF 1375.21.020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390080460), received between Sep 13, 2017 and Sep 13, 2017 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 13, 2017Loose or Intermittent Connection; Device Dislodged or Dislocated

  RIGHT SHOULDER REVISION SURGERY DONE ON (B)(6) 2017 DUE TO RECURRENT IMPLANT DISLOCATION. ORIGINAL SURGERY WAS PERFORMED ON (B)(6) 2017. DURING THE REVISION SURGERY, METAL BACK, GLENOSPHERE, REVERSE POLY LINER AND REVERSE HUMERAL BODY WERE REMOVED, ILIAC BONE WAS TRANSPLANTED IN THE GLENOID AND A CTA HEAD WAS INSERTED TOGETHER WITH A NEW HUMERAL BODY. ACCORDING TO THE INFO REPORTED, THE INCREASED USE FREQUENCY OF THE RIGHT ARM DUE TO CARPAL TUNNEL RELEASE ON THE LEFT HAND MAY HAVE LED THE GLENOID COMPONENT TO BECAME STRESSED, THUS LEADING TO LOOSENING OF THE GLENOID CONSTRUCT (METAL BACK + GLENOSPHERE) FROM THE GLENOID BONE AND THEREFORE TO CONTINUOUS DISLOCATION. EVENT HAPPENED IN (B)(6).

  Patient problems: No Code Available

  MAUDE report 6860904 ↗