SMR Metal Back Uncemented Glenoid (REF 1375.21.005)Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390080446), received between Feb 1, 2017 and Jun 18, 2018 — classified as 4 injuries.

The most frequently reported specific device problem is “Component Incompatible” (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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJun 18, 2018Improper or Incorrect Procedure or Method

  DURING SURGERY, AFTER PROSTHESIS REDUCTION, IT WAS FOUND THAT THE METAL BACK GLENOID ALREADY IMPLANTED FAILED TO BE FIXED AS A CONSEQUENCE OF THE PATIENT'S GLENOID CAVITY OF SCAPULA FRACTURED (ROOT CAUSE OF BONE FRACTURE IS UNKNOWN, BUT PATIENT SUFFERS OF PRE-EXISTING RHEUMATOID ARTHRITIS). THEN, A HUMERAL HEAD REPLACEMENT WAS IMMEDIATELY NEEDED CAUSING A PROLONGED SURGERY TIME OF 30 MINUTES. SURGEON SATISFIED WITH THE FINAL STABILITY OF THE IMPLANT. EVENT HAPPENED IN (B)(6) ON (B)(6) 2018.

  Patient problems: Bone Fracture(s)

  MAUDE report 7608837 ↗
• InjurySep 22, 2017Adverse Event Without Identified Device or Use Problem

  AT THE 6 MONTH-FOLLOW-UP, ON (B)(6) 2016, SCAPULAR SPINE FRACTURE WAS OBSERVED. ACCORDING TO THE INFO REPORTED, SURGEON JUDGED THIS SCAPULAR SPINE FRACTURE AS NON SERIOUS. NEITHER REVISION SURGERY PERFORMED NOR PLANNED (WAIT-AND-SEE APPROACH ADOPTED BY SUSPENDING THE PREVIOUS REHABILITATION). EVENT HAPPENED ON JAPAN.

  Patient problems: Bone Fracture(s)

  MAUDE report 6886068 ↗
• InjuryAug 7, 2017Torn Material

  ON (B)(6) 2016 THE PATIENT UNDERWENT SHOULDER ARTHROPLASTY AND A SMR REVERSE PROSTHESIS WAS IMPLANTED. THE PATIENT SUFFERED OF MASSIVE ROTATOR CUFF TEAR ON THE RIGHT SHOULDER. ON (B)(6) 2016 THE PATIENT UNDERWENT A ROUTINE MEDICAL CHECK AND THE X-RAYS SHOWED OSTEOLYSIS AROUND THE PEG OF THE METAL BACK GLENOID. THE PATIENT WAS NOT EXPERIENCING ANY PAIN. AT THAT TIME, THE SURGEON DECIDED THAT THE SITUATION WAS NOT SERIOUS AND THAT THE BONE SCREWS SEEMED NOT TO BE LOOSE, HENCE THE REVISION SURGERY WAS NOT PERFORMED. MOREOVER, THE SURGEON STATED THAT HE HAD NO IDEA ON THE POSSIBLE CAUSES OF THE OSTEOLYSIS. HOWEVER, AN INFECTION CANNOT BE EXCLUDED. EVENT HAPPENED IN JAPAN.

  Patient problems: Osteolysis; Unspecified Infection

  MAUDE report 6770048 ↗
• InjuryFeb 1, 2017Component Incompatible; Device Dislodged or Dislocated

  ON (B)(6) 2016, SMR SYSTEM WAS PLACED TO THE PATIENT WITH CUFF TEAR ARTHROPATHY. ON (B)(6) 2016, POST-OP X-RAYS REVEALED THE DISLOCATION OF THE GLENOSPHERE AND THEN, CT SCANS SHOWED BONE FRACTURE AND BACK-SHIFT OF GLENOID BONE. THE WHOLE CONSTRUCT GLENOSPHERE + METAL BACK, WELL FIXED ONE EACH OTHER, HAD COME OUT FROM THE GLENOID BONE. ACCORDING TO THE INFO REPORTED, NO FALL NOR HEAVY EXERCISES AFTER SURGERY BUT PATIENT BONE QUALITY WAS A LITTLE FRAGILE. IT WAS NOTICED THAT, ONCE RECEIVED REHABILITATION, THE PATIENT DID FINE. REVISION SURGERY NOT YET PERFORMED. SURGEON'S REMARKS: "THE LOWER BONE SCREW MAY HAVE BEEN TOO SHORT (20MM) AND HAVE NOT WORKED WELL". THE EVENT OCCURRED IN JAPAN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 6292405 ↗