SMR Shoulder 1304.15.017Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 08033390155328), received between Jun 22, 2026 and Jun 22, 2026 — classified as 1 injury.

The most frequently reported specific device problem is “Packaging Problem” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJun 22, 2026Packaging Problem

  ON (B)(6) 2026, AN INTRA-OPERATIVE ISSUE OCCURRED DURING A PLANNED RIGHT REVERSE SHOULDER ARTHROPLASTY. THE SURGEON INTENDED TO IMPLANT A SHORT STEM D.17 MM L: 45 MM (PRODUCT CODE: 1304.15.017). DURING THE PROCEDURE, IT WAS IDENTIFIED THAT THE IMPLANT CONTAINED INSIDE THE PACKAGE LABELED AS SMR FINNED STEM SHORT D.17 MM L: 45 MM (PRODUCT CODE: 1304.15.017, LOT: 2535515 - STER: (B)(4)) WAS NOT A SHORT STEM, BUT A STANDARD STEM D.17 MM L: 80 MM (PRODUCT CODE: 1304.15.170 - LOT: UNKNOWN). THEREFORE, A SHORT STEM PACKAGE APPARENTLY CONTAINED A STANDARD STEM INSTEAD OF THE CORRECTLY LABELED IMPLANT. IT WAS REPORTED THAT THE INVOLVED DEVICE (PRODUCT CODE: 1304.15.017, LOT: 2535515 - STER: (B)(4)) WAS RECEIVED STERILE AND SHOWED NO EVIDENCE OF SEAL BREACH. THIS MISMATCH WAS DISCOVERED DURING SURGERY AFTER OPENING AND IMPLANTATION. AS THE IMPLANT HAD ALREADY BEEN INSERTED AT THE TIME THE DISCREPANCY WAS IDENTIFIED, THE STANDARD STEM WAS LEFT IN SITU. THE SURGEON WAS SATISFIED AND THE RESULT WAS GOOD. THERE WAS A DELAY OF 2-3 MINUTES. ACCORDING TO COMPLAINT SOURCES, THE HUMERUS WAS PREPARED FOR A STANDARD STEM, BUT INTRAOPERATIVELY IT WAS THEN SWITCHED TO A SHORT STEM BECAUSE THIS SUITED TH

  Patient problems: Insufficient Information

  MAUDE report 25574644 ↗