Titan™ IMP-0961-064-SRecalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10381780467786), received between May 4, 2022 and Dec 26, 2022 — classified as 14 malfunctions.

The most frequently reported specific device problem is “Break” (8 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.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING USE, THE BLACK TIP ON A RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF DURING INSERTION OF THE BASEPLATE. HOWEVER, ALL PIECES WERE RECOVERED. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048707 ↗
• MalfunctionDec 26, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING A SHOULDER ARTHROPLASTY, THE TIP OF THE RSS GLENOID BASEPLATE IMPACTOR-S DEVICE WAS FOUND TO BE BROKEN. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO PIECES FELL IN PATIENT. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16048651 ↗
• MalfunctionOct 26, 2022Break; Break

  IT WAS REPORTED THAT, DURING A REVERSE SHOULDER REPLACEMENT SURGERY, THE PLASTIC END OF THE RSS GLENOID BASEPLATE IMPACTOR-S BROKE WHILE USING. NO PIECES FELL INSIDE OF THE PATIENT. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15674243 ↗
• MalfunctionSep 1, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE BLACK PART OF A RSS GLENOID BASEPLATE IMPACTOR-S BROKE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15337663 ↗
• MalfunctionAug 29, 2022Fracture; Fracture

  IT WAS REPORTED THAT DURING SET UP FOR A REVERSE SHOULDER SYSTEM-S PROCEDURE, THE PLASTIC TIP OF A RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF. AS THIS HAPPENED BEFORE SURGERY, PATIENT WAS NOT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15312683 ↗
• MalfunctionJul 30, 2022Break; Break

  IT WAS REPORTED THAT, DURING SET UP OR INSPECTION, THE TIP OF THE RSS GLENOID BASEPLATE IMPACTOR-S BROKE OFF PRIOR TO USE, BEFORE INSERTING BASEPLATE. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136777 ↗
• MalfunctionJul 29, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, THE LITTLE METAL PEGS (DOWEL PINS) OF THE RSS GLENOID BASEPLATE IMPACTOR-S, THAT HOLD ROTATIONAL STABILITY ON THE IMPLANT WHILE INSERTING, WENT MISSING. AS THIS WAS NOTICED IN A FIELD INSPECTION, NO PATIENT WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15136619 ↗
• MalfunctionJul 27, 2022Break; Break

  IT WAS REPORTED THAT DURING STERILE PROCESSING DECONTAMINATION (SPD) THE RSS GLENOID BASEPLATE IMPACTOR-S BROKE ON THE PLASTIC TIP. NO CASE WAS INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15113836 ↗
• MalfunctionJul 20, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING SPD ACTIVITIES, IT WAS NOTICED THAT THE TIP OF THE RSS GLENOID BASEPLATE IMPACTOR-S WAS BROKEN OFF. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15068404 ↗
• MalfunctionJul 13, 2022Break; Break

  IT WAS REPORTED THAT DURING SURGERY TWO RSS GLENOID BASEPLATE IMPACTOR-S TIPS WERE NOTICED BROKEN. ALL PIECES WERE RECOVERED. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING AN S+N BACKUP DEVICE. NO FURTHER COMPLICATION WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15008975 ↗
• MalfunctionMay 11, 2022Break; Break

  IT WAS REPORTED THAT, DURING A REVERSE TOTAL SHOULDER SURGERY, THE TIP OF A RSS GLENOID BASEPLATE IMPACTOR-S IS BROKEN OFF. NO PIECES FELT INSIDE PATIENT. THE PROCEDURE WAS COMPLETED, WITHOUT DELAY, USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14366189 ↗
• MalfunctionMay 6, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT, THE PLASTIC TIPS OF AN RSS GLENOID BASEPLATE IMPACTOR-S HAVE WORN DOWN AND BROKEN OFF AFTER EXTENSIVE USE. NO CASE REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14307582 ↗
• MalfunctionMay 5, 2022Break; Material Deformation; Break; Material Deformation

  IT WAS REPORTED THAT THE PLASTIC TIPS OF AN RSS GLENOID BASEPLATE IMPACTOR-S HAVE WORN DOWN AND BROKEN OFF AFTER EXTENSIVE USE. NO CASE WAS REPORTED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14291988 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A REVERSE SHOULDER PROCEDURE, THE RSS GLENOID BASEPLATE IMPACTOR-S WAS BROKEN. AS THIS HAPPENED AFTER THE PROCEDURE, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283238 ↗