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Titan Reverse Shoulder System IMP-0961-064-SRecalls & reported problems

Smith & Nephew, Inc. · RSS GLENOID BASEPLATE IMPACTOR-S · Class 1

All models of Titan Reverse Shoulder System (18)

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

Quick summary

This Smith & Nephew RSS Glenoid Baseplate Impactor-S is a hand instrument used during reverse shoulder replacement surgery to seat the shoulder socket baseplate. The 36 reports mostly describe the tool breaking during surgery, sometimes with its tip or small securing tips snapping off into the implant, which then has to be retrieved and the instrument replaced. There are 36 reports, with 1 injury and no deaths, and no recalls name this device. Reports in the last 12 months fell to 4, down from 13 the year before.

AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.

Adverse event reports
36
Deaths reported
0
Injuries reported
1
Recalls naming it
0

Summary

The FDA's MAUDE database contains 36 adverse event reports that list this exact device (DI 00885556863947), received between Feb 15, 2023 and Jun 10, 2026 — classified as 1 injury, 35 malfunctions.

The most frequently reported specific device problem is “Fracture” (28 reports).

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.

Reports received per month

Nov 2023: 0 reportsDec 2023: 1 reportsJan 2024: 0 reportsFeb 2024: 5 reportsMar 2024: 0 reportsApr 2024: 3 reportsMay 2024: 0 reportsJun 2024: 0 reportsJul 2024: 1 reportsAug 2024: 0 reportsSep 2024: 1 reportsOct 2024: 1 reportsNov 2024: 1 reportsDec 2024: 3 reportsJan 2025: 1 reportsFeb 2025: 0 reportsMar 2025: 3 reportsApr 2025: 0 reportsMay 2025: 2 reportsJun 2025: 1 reportsJul 2025: 0 reportsAug 2025: 0 reportsSep 2025: 1 reportsOct 2025: 1 reportsNov 2025: 0 reportsDec 2025: 2 reportsJan 2026: 0 reportsFeb 2026: 0 reportsMar 2026: 0 reportsApr 2026: 0 reportsMay 2026: 1 reportsJun 2026: 1 reportsJul 2026: 0 reportsAug 2026: 0 reportsSep 2026: 0 reportsOct 2026: 0 reports2024202520265
Last 36 months. The most recent month may be incomplete.

Most reported problems

Device problems

  • Fracture28
  • Break10
  • Detachment of Device or Device Component2

Patient problems

  • No Clinical Signs, Symptoms or Conditions36

Recent adverse event reports

The 25 most recent of 36 reports, in the reporter's own words as published by the FDA.

  • MalfunctionJun 10, 2026Break

    IT WAS REPORTED THAT, DURING A SHOULDER SURGERY, ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK-UP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25465635 ↗
  • MalfunctionMay 5, 2026Break

    IT WAS REPORTED THAT, DURING A REVERSE SHOULDER REPLACEMENT SURGERY, THE RSS GLENOID BASEPLATE IMPACTOR-S BROKE. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK UP. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 25089507 ↗
  • MalfunctionDec 1, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING SURGERY, SURGEON BROKE THE RSS GLENOID BASEPLATE IMPACTOR-S. IT IS UNKNOWN HOW PROCEDURE WAS PERFORMED AND IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23687011 ↗
  • MalfunctionDec 1, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING SURGERY, SURGEON BROKE THE RSS GLENOID BASEPLATE IMPACTOR-S. IT IS UNKNOWN HOW PROCEDURE WAS PERFORMED AND IF THERE WAS ANY DELAY. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23686919 ↗
  • MalfunctionOct 30, 2025Break; Break

    IT WAS REPORTED THAT, DURING REVERSE SHOULDER SURGERY, THE SURGEON BROKE ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED, OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23426656 ↗
  • MalfunctionSep 28, 2025Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

    IT WAS REPORTED THAT DURING A REVERSE SHOULDER ARTHROPLASTY, WHILE THE SURGEON WAS IMPLANTING THE GLENOID BASEPLATE WITH ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S, THE TWO BLACK TIPS THAT SECURE THE IMPLANT BROKE OFF INTO THE IMPLANT WHEN THE SURGEON ATTEMPTED TO DISENGAGE THE IMPACTOR. THE SURGEON SUCCESSFULLY RETRIEVED THE BROKEN PIECES WITHOUT COMPLICATION; HOWEVER, THE IMPACTOR HAS BEEN RENDERED UNUSABLE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 23163855 ↗
  • MalfunctionJun 24, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING TITAN REVERSE SHOULDER ARTHROPLASTY, THE SURGEON BROKE THE TIP ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S. IT IS UNKNOWN HOW WAS THE PROCEDURE FINISHED, OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22312974 ↗
  • MalfunctionMay 21, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING TOTAL REVERSE SHOULDER SURGERY THE TIP OF ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22061723 ↗
  • MalfunctionMay 14, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING TITAN REVERSE SHOULDER SURGERY, THE SURGEON BROKE THE TIP OF ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S. IT IS UNKNOWN HOW THE PROCEDURE FINISHED, OR IF IT CAUSED ANY DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 22023320 ↗
  • MalfunctionMar 11, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING SHOULDER ARTHROPLASTY, THE BLACK PLASTIC OF A RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF. PIECES WERE RETRIEVED, BUT IT IS UNKNOWN IF THEY HAD TO BE EXTRACTED FROM THE PATIENT. AT THIS TIME, IT IS UNKNOWN IF THERE WAS A DELAY OR HOW PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21574032 ↗
  • MalfunctionMar 6, 2025Fracture; Fracture

    IT WAS REPORTED THAT DURING A TSA, THE TIP ON TWO (2) RSS GLENOID BASEPLATE IMPACTOR-S (BLACK PART), BROKE OFF. NO PIECES FELL INSIDE THE PATIENT'S ANATOMY. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. NO PATIENT COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21537241 ↗
  • MalfunctionMar 5, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING A TSA, WHILE INSERTING THE GLENOID, THE MIDDLE POST OF A (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF. THE PROCEDURE WAS RESUMED USING A S+N BACK-UP DEVICE, BUT IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21531780 ↗
  • MalfunctionJan 9, 2025Fracture; Fracture

    IT WAS REPORTED THAT, DURING A REVERSE SHOULDER ARTHROPLASTY, ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE AT THE BLACK PLASTIC TIP. NO PARTS REMAINED INSIDE THE PATIENT. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED AND IF THERE WAS ANY DELAY.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21113077 ↗
  • MalfunctionDec 31, 2024Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

    IT WAS REPORTED THAT, A RSS GLENOID BASEPLATE IMPACTOR-S BROKE IN A TITAN REVERSE SURGERY. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF A DELAY WAS REPORTED. NO FURTHER COMPLICATIONS WERE REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21047616 ↗
  • MalfunctionDec 29, 2024Break; Break

    IT WAS REPORTED THAT, DURING A REVISION TSA SURGERY, ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS COMPLETED, AND IF THERE WAS SURGICAL DELAY. NO INJURIES WERE REPORTED AS A RESULT.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 21032129 ↗
  • MalfunctionDec 20, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING SURGERY, THE BLACK END OF A RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF WHILE THE DOCTOR WAS USING THE IMPACTOR. NO PIECES FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20995747 ↗
  • MalfunctionNov 26, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING SURGERY, THE TIP OF ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF. IT IS UNKNOW HOW WAS THE PROCEDURE COMPLETED. NO DELAY NOR INJURY WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20778871 ↗
  • MalfunctionOct 18, 2024Fracture; Fracture

    IT WAS REPORTED THAT DURING SURGERY, THE PLASTIC TIP OF A RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF THE END. ALL PIECES WERE RETRIEVED FROM THE PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20487896 ↗
  • MalfunctionSep 27, 2024Break; Break

    IT WAS REPORTED THAT, DURING REVERSE TOTAL SHOULDER SURGERY, ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 20322283 ↗
  • MalfunctionJul 12, 2024Break; Break

    IT WAS REPORTED THAT, DURING A TITAN CASE, THE BLACK TIP ON THE END OF ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE. IT IS UNKNOWN IF THE PROCEDURE WAS DELAYED AND HOW IT WAS COMPLETED. PATIENT WAS NOT HARMED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19730899 ↗
  • MalfunctionApr 19, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING TITAN REVERSE SHOULDER SURGERY, THE BLACK PLASTIC TIP ON THE END OF ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE WHILE IMPACTING. NOTHING FELL INSIDE THE WOUND. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, IT IS UNKNOWN HOW. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19142660 ↗
  • MalfunctionApr 16, 2024Break; Break

    IT WAS REPORTED THAT DURING SURGERY, THE RSS GLENOID BASEPLATE IMPACTOR-S BROKE. IT IS UNKNOWN HOW WAS THE PROCEDURE COMPLETED AND IF A DELAY WAS PRESENTED. NO INJURY TO PATIENT WAS REPORTED.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19116412 ↗
  • MalfunctionApr 2, 2024Break; Fracture; Break; Fracture

    IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER ARTHROPLASTY, THE BASEPLATE OF A RSS GLENOID BASEPLATE IMPACTOR-S BROKE. IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED OR IF THERE WAS ANY PROCEDURAL DELAY. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 19020662 ↗
  • MalfunctionFeb 19, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING REVERSE SHOULDER SURGERY, UPON STRIKING WITH MALLET AND REMOVING SHAFT, BLACK TIP OF ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18734943 ↗
  • MalfunctionFeb 19, 2024Fracture; Fracture

    IT WAS REPORTED THAT, DURING REVERSE SHOULDER SURGERY, UPON STRIKING WITH MALLET AND REMOVING SHAFT, BLACK TIP OF ONE (1) RSS GLENOID BASEPLATE IMPACTOR-S BROKE. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

    Patient problems: No Clinical Signs, Symptoms or Conditions

    MAUDE report 18734636 ↗

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Sources and updates

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