SMR Shoulder Humeral Body (REF 1350.15.110)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390002035), received between Jul 25, 2025 and Jan 2, 2026 — classified as 3 injuries.

The most frequently reported specific device problem is “Unstable” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryJan 2, 2026Unstable

  SHOULDER REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO INSTABILITY. THE FOLLOWING PRODUCT WAS REMOVED: SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER UNKNOWN AND STERILIZATION UNKNOWN). ACCORDING TO THE INFORMATION AVAILABLE SO FAR, THERE WERE ALSO OTHER COMPONENTS THAT WERE REMOVED TOGETHER WITH THE SMR FINNED HUMERAL BODY BUT COULD NOT GET THE IMPLANT INFORMATION OR SIZES FOR THEM. DATE OF REVISION SURGERY IS UNKNOWN. THE PATIENT IS FEMALE, DATE OF BIRTH (B)(6) 1952. THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Insufficient Information

  MAUDE report 23944367 ↗
• InjuryDec 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025 DUE TO PAIN AND SUSPECTED INFECTION. PATIENT WAS EXPERIENCING PAIN, SURGEON SUSPECTED INFECTION. FOLLOWING COMPONENTS WERE REMOVED DURING SURGERY: - SMR HUMERAL HEAD D.46 H.15MM (PART NUMBER 1321.09.461, LOT NUMBER 2200510, STERILIZATION 2200067), - SMR ECC.ADAPTOR TAPER STANDARD (PART NUMBER 1330.15.274, LOT NUMBER 2013120, STERILIZATION 2000264), - SMR FINNED HUMERAL BODY (PART NUMBER 1350.15.110, LOT NUMBER 2213920, STERILIZATION 2200221) - CEMENTED GLENOID 3 PEGS SMALL (PART NUMBER 1379.50.020, LOT NUMBER 20AT5EG, STERILIZATION 2200049). REVERSE CONFIGURATION (REVERSE HUMERAL BODY PART NUMBER 1352.15.005, EXTENSION FOR HUMERAL REVERSE BODY PART NUMBER 1352.15.001, RETENTIVE LINER PART NUMBER 1361.50.815) WAS IMPLANTED DURING REVISION. PREVIOUS SURGERY DATE IS UNKNOWN. PATIENT IS MALE, DATE OF BIRTH (B)(6)1955. THE EVENT OCCURRED IN THE UNITED STATES.

  Patient problems: Implant Pain; Medical device site infection

  MAUDE report 23693253 ↗
• InjuryJul 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SHOULDER REVISION SURGERY WAS PERFORMED ON (B)(6) 2025, DUE TO ROTATOR CUFF FAILURE. THE PATIENTS CUFF GAVE OUT AND WE HAD TO CONVERT FROM AN ANATOMIC TO A REVERSE CONSTRUCT. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR FINNED HUMERAL BODY (PART CODE 1350.15.110, LOT NUMBER 2221215, STERILIZATION (B)(4)). - LINER F.MET.BACK GLEN.STANDARD (PART CODE 1377.50.010, LOT NUMBER 21AT27C, STERILIZATION UNKNOWN). PREVIOUS SURGERY TOOK PLACE ON (B)(6) 2023. THE PATIENT IS A FEMALE, DATE OF BIRTH (B)(6). THE EVENT HAPPENED IN THE UNITED STATES.

  Patient problems: Muscle/Tendon Damage

  MAUDE report 22609501 ↗