SMR Shoulder Finned Stem (REF 1304.15.140)Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 08033390000888), received between Oct 10, 2017 and Jul 1, 2025 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (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. How this data works · Data updated Oct 13, 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.

• MalfunctionJul 1, 2025Mechanical Problem; Product Quality Problem; Mechanical Problem; Product Quality Problem

  DURING RSA ON (B)(6) 2025, TRIAL STEM (14MM) WAS FIRMLY FIXED. HOWEVER, DEFINITIVE STEM (14MM) WAS LOOSE AND SPUN AROUND ON THE PATIENT. THE SURGEON PERFORMED TRIALING AGAIN, AND DEFINITIVE STEM (16MM) WAS IMPLANTED. DUE TO THE EVENT, SURGICAL TIME WAS EXTENDED FOR ABOUT 20 MINUTES. BELOW IS THE SUSPECTED PRODUCT: · SMR CEMENTLESS FINNED STEM (PRODUCT CODE 1304.15.140, LOT #2431073 - STER. #2500015) - PRODUCT SOLD IN US. THE PATIENT IS A 75 -YEAR-OLD MALE. EVENT HAPPENED IN JAPAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22368592 ↗
• InjuryMay 6, 2025Patient Device Interaction Problem; Patient Device Interaction Problem

  REVISION SURGERY PERFORMED ON (B)(6) 2025, DUE TO POOR BONE QUALITY. THE STEM NEEDED TO BE UPSIZED. THE FOLLOWING COMPONENTS WERE REMOVED: - SMR CEMENTLESS FINNED STEM (PART CODE 1304.15.140, LOT NUMBER 2317201, STERILIZATION (B)(4)). - REVERSE HUMERAL BODY 140° (PART CODE 1352.15.011, LOT NUMBER 2414113, STERILIZATION (B)(4)). - SMR REV. LINER RETENTIVE +6 MM (PART CODE 1361.50.820, LOT NUMBER 20AT1UK, STERILIZATION (B)(4)). - SMR GLENOSPHERE DIA. 36MM (PART CODE 1374.09.111, LOT NUMBER 2433397, STERILIZATION (B)(4)). - SMR SMALL-R CONNECTOR +2 (PART CODE 1374.15.312, LOT NUMBER 2432234, STERILIZATION (B)(4)). THE ABOVE-MENTIONED COMPONENTS WERE REPLACED BY THE FOLLOWING NEW ONES: - SMR SMALL-R CONNECTOR +4 (PART CODE 1374.15.314, LOT NUMBER 2433782, STERILIZATION (B)(4)). - SMR GLENOSPHERE DIA. 40MM (PART CODE 1374.09.121, LOT NUMBER 2432907, STERILIZATION (B)(4)). - SMR FINNED STEM (PART CODE 1304.15.170, LOT NUMBER 2101797, STERILIZATION 2100099). - REVERSE HUMERAL BODY 140° (PART CODE 1352.15.011, LOT NUMBER 2422030, STERILIZATION (B)(4)). - EXTENSION FOR REVERSE HUMERAL BODY (PART CODE 1352.15.001, LOT NUMBER 2431805, STERILIZATION (B)(4)). - SMR REV. LINER RETENTIVE +3 MM (P

  Patient problems: Inadequate Osseointegration

  MAUDE report 21966244 ↗
• InjuryOct 10, 2017Fracture

  PATIENT SUFFERED OF OSTEOARTHRITIS AND SO, ON (B)(6) 2017, A SMR ANATOMIC TOTAL WAS IMPLANTED. CONVERSION TO SMR REVERSE WAS DONE ON(B)(6) 2017 DUE ROTATOR CUFF TEAR. DURING THE REVISION SURGERY, THE SURGEON WANTED TO KEEP AND PRESERVE THE CEMENTLESS STEM DIA.14MM BUT, ACCORDING TO THE INFO REPORTED, HE MAY HAVE TAPPED TOO MUCH WITH IMPACTOR WHEN TRYING TO COUPLE STEM AND HUMERAL BODY. EVENTUALLY, AS THEY DID NOT MANAGE TO CONNECT THE HUMERAL BODY WITH THE STEM, IT WAS DECIDED TO REMOVE THE STEM IN PLACE AND REPLACE IT WITH A 16MM STEM. THE INTRA-OPERATIVE X-RAYS THEN SHOWED THAT A DISTAL BONE FRACTURE HAD OCCURRED. IT WAS REPORTED THAT THE PLAN WAS TO OPERATE THE PATIENT AGAIN. EVENT HAPPENED IN JAPAN.

  Patient problems: Failure of Implant

  MAUDE report 6933710 ↗