Titan Modular Shoulder System 2.5 IMP-0926-030-00ARecalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556860724), received between May 12, 2023 and Oct 30, 2023 — classified as 4 malfunctions.

The most frequently reported specific device problem is “Fracture” (4 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 30, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING A TSA SURGERY, WHEN SURGEON WAS INSERTING THE FINLOCK IMPLANT USING A COMBO INSERTER/IMPACTOR. XS, ONE OF THE CLIPS ON THE INSTRUMENT BROKE OFF. SUCTION AND FORCEPS WERE USED TO REMOVE THE BROKEN PIECES. 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 18029453 ↗
• MalfunctionJun 14, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING TOTAL SHOULDER ARTHROPLASTY SURGERY, WHEN INSERTING THE FINLOCK IMPLANT INTO THE PATIENT, ONE OF THE ARMS OF THE COMBO INSERTER/IMPACTOR. XS BROKE OFF. THE BROKEN PART WAS REMOVED FROM THE PATIENT WITH FORCEPS AND SUCTION, AND THE SURGEON USED THE SECONDARY IMPACTOR TO ENSURE THE IMPLANT HAD GOOD CONTACT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17132239 ↗
• MalfunctionMay 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT WHILE INSERTING THE FINLOCK IMPLANT INTO THE PATIENT DURING A TSA, THE PLASTIC INSERTER OF THE COMBO INSERTER/IMPACTOR. XS BROKE. THE BROKEN PIECES WERE REMOVED WITH FORCEPS AND SUCTION FROM THE PATIENT. IT IS UNKNOWN HOW WAS THE SURGERY COMPLETED AND IF A DELAY WAS PRESENTED. NO INJURY TO PATIENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16970551 ↗
• MalfunctionMay 12, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A TSA SURGERY, WHILE INSERTING THE FIN-LOCK IMPLANT INTO THE PATIENT, TWO COMBO INSERTER/IMPACTOR. XS BROKE OFF. THE BROKEN PIECES WERE REMOVED WITH FORCEPS AND SUCTION FROM THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924684 ↗