Titan Reverse Shoulder System INS-0961-048-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556864005), received between Jun 9, 2023 and Dec 8, 2025 — classified as 7 malfunctions.

The most frequently reported specific device problem is “Fracture” (5 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 8, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A RTSA, THE THREADS OF ONE (1) RSS HUMERAL BODY INSERTER / EXTRACTOR BROKE WHEN DISASSEMBLING IT, AND THE RSS HUMERAL BODY INSERTER / EXTRACTOR STAYED ON THE IMPACTOR. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN SURGICAL TECHNIQUE. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23742524 ↗
• MalfunctionAug 14, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A RSA SURGERY, THE THREADED END OF ONE (1) RSS HUMERAL BODY INSERTER/EXTRACTOR BROKE OFF IN ONE (1) HUMERAL BODY TRIAL SML MOD MAKING IT UNUSABLE. THE BROKEN PIECE REMAINS IN THE SMALL BODY TRIAL. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, WITH A CHANGE IN THE SURGICAL TECHNIQUE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22811859 ↗
• MalfunctionMay 21, 2025Break; Break

  IT WAS REPORTED THAT DURING A TOTAL REVERSE REVISION SHOULDER ONE (1) RSS HUMERAL BODY INSERTER / EXTRACTOR 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 22067382 ↗
• MalfunctionJan 11, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING TSA SURGERY, ONE (1) TSS HEAD CUTTING TEMPLATE ROD. 2.5; ONE (1) RSS HUMERAL BODY INSERTER / EXTRACTOR AND ONE (1) COMBO INSERTER/IMPACTOR. M WERE BROKE DURING THE CASE. NO X-RAYS AVAILABLE, ITEMS WERE NOT BROKEN INSIDE PATIENT AND NO PIECES WERE LEFT IN PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICES. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18490765 ↗
• MalfunctionNov 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING AN RTSA SURGERY, IT WAS NOTICED THAT THE RSS HUMERAL BODY INSERTER / EXTRACTOR HAD A BROKEN PIECE OF THE VERSION ROD IN THE 30 DEGREE NOTCH. THIS LIKELY OCCURRED IN A PREVIOUS CASE BUT WAS DISCOVERED DURING THIS CASE. THE SURGERY WAS COMPLETED, WITHOUT ANY DELAY, WITH THE SAME REPORTED DEVICE. NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18121723 ↗
• MalfunctionSep 20, 2023Fracture; Fracture

  IT WAS REPORTED THAT, DURING REVERSE SHOULDER SURGERY, THE JUNCTION TIP OF AN RSS HUMERAL BODY INSERTER / EXTRACTOR BROKE OFF. THE PROCEDURE WAS COMPLETED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17784820 ↗
• MalfunctionJun 9, 2023No Apparent Adverse Event; No Apparent Adverse Event

  IT WAS REPORTED THAT DURING A ROTATOR CUFF ARTHROPATHY SURGERY, INSTRUMENT 7 FROM HUMERAL TRAY 1 BASE WAS PUT IN PLACE OF RSS HUMERAL BODY INSERTER / EXTRACTOR (INSTRUMENT 9) FOR THE REVERSE-S (BOTTOM TRAY), LEAVING THEM WITH 2 OF THE INSERTERS FROM HUMERAL TRAY AND NOT THE ONE NEEDED TO IMPLANT THE REVERSE. A S&N BACKUP DEVICE WAS AVAILABLE, HOWEVER, THERE WAS A SURGICAL DELAY GREATER THAN 30 MINS AND THE PATIENT WAS UNDER ANESTHESIA DURING SUCH DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17095831 ↗