SMR Shoulder Cemented Glenoid (REF 1379.50.010)Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 08033390096355), received between Sep 18, 2025 and Jan 29, 2026 — classified as 2 injuries.

The most frequently reported specific device problem is “Patient Device Interaction Problem” (2 reports).

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. How this data works · Data updated Oct 13, 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 29, 2026Patient Device Interaction Problem

  REVISION SURGERY WAS PERFORMED ON (B)(6) 2025 DUE TO LOOSENING. PATIENT HAD AN ANATOMIC REPLACEMENT AT UNKNOWN PRIOR DATE. NO COMPLETE INFORMATION REGARDING ORIGINAL IMPLANT COULD BE RETRIEVED. DUE TO LOOSENING OF CEMENTED 3-PEGGED GLENOID COMPONENT, SIGNIFICANT OSTEOLYSIS OCCURED. AFTER REMOVING THE GLENOID COMPONENT (PART NUMBER 1379.50.010), A MIXTURE OF BONE GRAFT AND DEMINERALIZED BONE MATRIX WAS USED TO FILL THE VOID. SURGEON DETERMINED THAT A REVERSE BASEPLATE WOULD NOT BE STABLE, AND THE PATIENT WAS REVISED TO HEMIARTHROPLASTY UTILIZING THE SAME SIZE ANATOMIC BODY, HEAD, AND ADAPTER AS WAS USED IN PREVIOUS CASE. SURGERY WAS COMPLETED AS INTENDED. THE PATIENT IS MALE, DATE OF BIRTH (B)(6) 1960. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Joint Laxity; Loose body in joint

  MAUDE report 24210890 ↗
• InjurySep 18, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO OSTEOLYSIS. THE PATIENT UNDERWENT PRIMARY SURGERY IN 2017 AND RECEIVED AN ANATOMIC SHOULDER REPLACEMENT UTILIZING SMR HUMERAL COMPONENTS AND STD 3-PEGGED CEMENTED GLENOID. DUE TO GLENOID IMPLANT LOOSENING OVER TIME, OSTEOLYSIS CAUSED SIGNIFICANT AMOUNT OF GLENOID BONE LOSS. THE FOLLOWING COMPONENTS WERE REMOVED AND DBM AND CANCELLOUS BONE CHIPS WERE USED TO GRAFT IN THE GLENOID: - SMR HUMERAL HEAD Ø50 MM (PART CODE 1322.09.500, LOT NUMBER 1707513, STERILIZATION 1700273). - SMR ECC.ADAPTOR TAPER STANDARD (PART CODE 1330.15.274, LOT NUMBER 1711206, STERILIZATION 1700318). - SMR TRAUMA HUM. BODY # MEDIUM (PART CODE 1350.15.010, LOT NUMBER 1710020, STERILIZATION 1700311). - CEMENT.GLENOID 3 PEGS STANDARD (PART CODE 1379.50.010, LOT NUMBER 15AT22U, STERILIZATION 1600115). NEW HUMERAL BODY, ADAPTER, AND HUMERAL HEAD WERE IMPLANTED ON (B)(6) 2025, AND THE PATIENT CURRENTLY HAS A HEMI ARTHROPLASTY UNTIL A SECOND PROCEDURE CAN BE UNDERGONE IN THE FUTURE TO IMPLANT A BASEPLATE. PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2017. THE PATIENT IS A MALE, DATE OF BIRTH (B)(6) 1953. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Joint Laxity

  MAUDE report 23083524 ↗