SMR Shoulder Cemented Glenoid (REF 1379.50.020)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390096362), received between Jan 2, 2026 and Jan 9, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJan 9, 2026Detachment of Device or Device Component

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING/DISASSEMBLY OF GLENOID COMPONENTS. PATIENT UNDERWENT PRIMARY SURGERY IN 2014 AND RECEIVED AN ANATOMIC SHOULDER REPLACEMENT UTILIZING SMR HUMERAL COMPONENTS INCLUDING: - SMR HUMERAL HEAD DIA 42MM (PART NUMBER 1322.09.420), - SMR ECC. ADAPTOR TAPER STANDARD (PART NUMBER 1330.15.272), - SMR TRAUMA HUMERAL BODY #MEDIUM (PART NUMBER 1350.15.010), AND SMALL 3-PEGGED CEMENTED GLENOID (PART NUMBER 1379.50.020, LOT UNKNOWN). DUE TO GLENOID IMPLANT LOOSENING OVER TIME, OSTEOLYSIS CAUSED SIGNIFICANT AMOUNT OF GLENOID BONE LOSS. ABOVE-MENTIONED COMPONENTS WERE REMOVED AND DEMINERALIZED BONE MATRICE AND CANCELLOUS BONE CHIPS WERE USED TO GRAFT IN THE GLENOID. NEW HUMERAL BODY, ADAPTER, AND HUMERAL HEAD WERE IMPLANTED AND PATIENT CURRENTLY HAS A HEMIARTHROPLASTY, UNTIL A SECOND PROCEDURE CAN BE UNDERGONE IN THE FUTURE TO IMPLANT A BASEPLATE. PATIENT IS A FEMALE, DATE OF BIRTH (B)(6) 1948. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Loose body in joint

  MAUDE report 24018190 ↗
• InjuryJan 2, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING OF THE CEMENTED GLENOID. PATIENT HAD A PRIOR ANATOMIC SHOULDER WITH CEMENTED 3-PEGGED POLY (PART NUMBER 1379.50.020, LOT UNKNOWN). AFTER LOOSENING OF THE POLY GLENOID WAS DETECTED IN A CLINIC VISIT, A TWO-STAGED REVISION WAS PLANNED. DURING REVISION SURGERY, 3-PEGGED CEMENTED POLY WAS REMOVED AND THE VOID IN GLENOID WAS FILLED WITH BONE GRAFT. A NEW HUMERAL HEAD (PART NUMBER 1324.09.461) AND ADAPTER (PART NUMBER 1330.15.270) OF THE SAME SIZE WERE IMPLANTED FOR RENEWAL REASONS, BUT NO DEFECT WERE REPORTED ON ORIGINAL HUMERAL COMPONENTS. HUMERAL BODY WAS INDEED RETAINED. PREVIOUS SURGERY DATE IS UNKNOWN. PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1962. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 23943074 ↗