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Titan Reverse Shoulder System HDL-0960-065-01Recalls & reported problems

Smith & Nephew, Inc. · RSS GLENOSPHERE INSERTER · Class 1

All models of Titan Reverse Shoulder System (18)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
1
Deaths reported
0
Injuries reported
0
Recalls naming it
0

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556863879), received between Apr 6, 2023 and Apr 6, 2023 — classified as 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. What reports can and can't tell you · How this data works · Data updated Oct 18, 2026.

Most reported problems

Device problems

  • Fracture1

Patient problems

  • No Clinical Signs, Symptoms or Conditions1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • MalfunctionApr 6, 2023Fracture; Fracture

    IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF THE RSS GLENOSPHERE INSERTER BROKE AS THE GLENOSPHERE WAS BEING IMPACTED/INSERTED IN TO THE BASEPLATE. THE SURGERY WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, BUT IT IS UNKNOWN HOW. NO INJURIES WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 16690440 ↗

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Sources and updates

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