SMR System 1374.50.400Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 08033390061230), received between Sep 24, 2025 and Feb 25, 2026 — classified as 4 injuries.

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

• InjuryFeb 25, 2026Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2026. PATIENT COMPLAINING OF STIFFNESS, LOSS OF FUNCTION AND RANGE OF MOTION. THERE WAS NO PAIN REPORTED. DURING THE REVISION THE FOLLOWING DEVICES WERE REPLACED: SMR REVERSE HP LAT. LINER LONG (PRODUCT CODE: 1365.09.120, LOT: 2317383 - STER: (B)(6)) - SOLD IN US. SMR CONNECTOR SMALL STD (PRODUCT CODE:1374.15.310, LOT: 2202385 - STER: (B)(6)) - SOLD IN US SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE: 1374.50.400, LOT: 2512220 - STER: (B)(6)) - SOLD IN US. PREVIOUS SURGERY PERFORMED ON (B)(6) 2025. ACCORDING TO THE COMPLAINT SOURCE THE REHAB WAS TOO CONSERVATIVE, LEADING THE SYMPTOMS. EVENT OCCURRED IN CANADA.

  Patient problems: Loss of Range of Motion

  MAUDE report 24444020 ↗
• InjuryJan 30, 2026Device Dislodged or Dislocated

  A SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2026, DUE TO IMPLANT DISLOCATION/LUXATION FOR UNKNOWN REASONS. DURING THE REVISION PROCEDURE, THE SURGEON EXPLANTED THE LINER, GLENOSPHERE, AND CONNECTOR PIN, WHICH WERE SUBSEQUENTLY REPLACED WITH CUSTOM COMPONENTS. THE PREVIOUS SHOULDER SURGERY WAS PERFORMED ON (B)(6) 2024. THE FOLLOWING DEVICES WERE INVOLVED IN THE PROCEDURE: SMR REV. HP LAT. LINER MEDIUM (PRODUCT CODE 1365.09.115, LOT #2322245 - STER. (B)(4) SMR SMALL-R CONNECTOR +4 (PRODUCT CODE 1374.15.314, LOT #2332997 - STER. (B)(4) SMR REVERSE HP GLENOSPHERE 40 MM (PRODUCT CODE 1374.50.400, LOT #2330500 - STER. (B)(4) THE PATIENT IS A FEMALE, BORN ON (B)(6) 1948, WITH A HIGH BMI LEVEL AND A VERY LOW ACTIVITY LEVEL. NO ADDITIONAL CLINICAL INFORMATION IS AVAILABLE. THE EVENT OCCURRED IN AUSTRALIA.

  Patient problems: Joint Dislocation

  MAUDE report 24222955 ↗
• InjuryJan 19, 2026Break; Detachment of Device or Device Component

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO POTENTIAL GLENOSPHERE LOOSE FROM MALE CONNECTOR IN GLENOID BASEPLATE. PATIENT STARTED TO HAVE MORE CLICKING AND PAIN IN SHOULDER 18 MONTHS PRIOR. THE SYMPTOMS WERE NOTICED OVER TIME AND NO SPECIFIC EVENT OR INJURY. PATIENT OTHERWISE FIT AND WELL. TWO PIECES OF METAL NOTED ON RECENT X-RAYS FROM GLENOSPHERE WIRE. GLENOSPHERE REVISED - MOST OF METAL WIRE REMOVED BUT NOT ALL. A SMALL FRAGMENT OF WIRE COULD NOT BE FOUND. PREVIOUS SURGERY PERFORMED ON (B)(6) 2020. THE EXPLANTED DEVICES: · SMR CONNECTOR SMALL STD (PRODUCT CODE: 1374.15.310, LOT: 1810021 - STER: 1800219) · SMR REVERSE HP GLENOSPH. 40 MM (PRODUCT CODE: 1374.50.400, LOT: 2001378 - STER: 2000040) · SMR REVERSE HP LINER LONG (PRODUCT CODE: 1365.09.020, LOT: 1918642 - STER: 1900463) PATIENT: MALE, 68 YEARS OLD, HEIGHT: 1.72M, WEIGHT: 82KG, OCCUPATION: DIVING, EVENT OCCURRED IN UNITED KINGDOM.

  Patient problems: Pain

  MAUDE report 24108817 ↗
• InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHOULDER REVISION SURGERY OF A SMR REVERSE PROSTHESES PERFORMED ON (B)(6) 2025, DUE TO POSSIBLE INFECTION AND ARTHROFIBROSIS WITH STIFFNESS. REMOVAL OF GLENOSPHERE AND REVERSE BODY AND PUTTING IN A NEW 140-DEGREE HUMERAL BODY, HUMERAL LINER AND 40 MM GLENOSPHERE. THE FOLLOWING DEVICES WERE EXPLANTED: · SMR REVERSE HUMERAL BODY (PRODUCT CODE 1352.20.010, LOT # 2419882- STER. (B)(4)) - SOLD IN US. · SMR REVERSE HP LINER MEDIUM (PRODUCT CODE 1362.09.015, LOT #2228636 - STER. (B)(4)). · SMR REVERSE HP GLENOSPHERE 44 MM (PRODUCT CODE 1374.50.440, LOT # 2425153- STER. (B)(4)) - SOLD IN US. · BONE SCREW Ø6,5 H.25MM (PRODUCT CODE 8420.15.020, LOT #2330524- STER. (B)(4)) - SOLD IN US THE PREVIOUS SURGERY WAS PERFORMED ON (B)(6) 2024. EVENT HAPPENED IN AUSTRALIA.

  Patient problems: Medical device site infection; Scar Tissue

  MAUDE report 23130496 ↗