NA 2598-07-435Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295148418), received between May 15, 2018 and Dec 26, 2025 — classified as 1 injury, 12 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (10 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 16, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 26, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT INSTRUMENT WAS STUCK TOGETHER. IT DID NOT HAPPEN DURING A SURGICAL PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23895617 ↗
• MalfunctionJul 23, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE STEM INSERTERS WERE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22577583 ↗
• MalfunctionJan 15, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE UNIVERSAL STEM INSERT HANDLE AND THE BULLET TIP STEM INSERTER SHAFT DO NOT LOCK TOGETHER.

  Patient problems: Insufficient Information

  MAUDE report 21162158 ↗
• MalfunctionOct 12, 2023Device-Device Incompatibility; Device-Device Incompatibility

  UNIVERSAL HANDLE AND THE BULLET TIP INSERTER WILL NOT CLICK TOGETHER. UNKNOWN WHICH PIECE IS THE ISSUE. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17926582 ↗
• MalfunctionAug 14, 2023Device-Device Incompatibility; Device-Device Incompatibility

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE MODULAR PIECE DOES NOT GO INTO THE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17541472 ↗
• MalfunctionAug 15, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM IMPACTION HANDLE AND BULLET TIP IMPACTOR ARE STUCK TOGETHER. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15228875 ↗
• MalfunctionJun 8, 2022Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM IMPACTOR THAT WAS STUCK IN THE HANDLE AND WILL NOT COME LOOSE. UPON BREAKING DOWN INSTRUMENTS POST OP AFTER MULTIPLE ATTEMPTS, COULD NOT BREAK FREE THE INSERTER OR INSERTER HANDLE. THIS DID NOT DELAY SURGERY AS SURGERY WAS OVER. NO ONE WAS INJURED. RETURNING IT FOR INSPECTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14631623 ↗
• MalfunctionFeb 22, 2021Device-Device Incompatibility; Material Integrity Problem; Material Twisted/Bent; Device-Device Incompatibility; Material Integrity Problem; Material Twisted/Bent

  THE END OF THE IMPACTOR IS WORN OUT/DAMAGED AND WILL NOT ATTACH BACK ONTO THE UNIVERSAL HANDLE. WAS NOT USED IN CASE, HAPPENED PRE-OPERATIVELY. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11358610 ↗
• MalfunctionJul 1, 2020Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking; Device-Device Incompatibility; Adverse Event Without Identified Device or Use Problem; Physical Resistance/Sticking

  THE IMPACTOR HANDLE AND IMPACTOR SHAFT WERE REPORTED FOR UNKNOWN REASON. THERE WAS NO DELAY TO SURGERY. THE ISSUE WAS FOUND IN SPD.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10217591 ↗
• InjuryJul 2, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT AFTER IMPACTION, THE STEM SAT UP PROUD AND WOULDN¿T FULLY SEAT. STEM EXTRACTORS WOULDN¿T THREAD INTO THE IMPLANT TO EXTRACT. BELIEVED THE BULLET TOO INSERTER MAY HAVE DAMAGED THE THREADS ON IMPACTION. THERE WAS A 30 MINUTES SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 8754278 ↗
• MalfunctionMar 1, 2019Difficult to Remove; Scratched Material; Difficult to Remove; Scratched Material

  IT WAS REPORTED THAT THE BULLET TIP STEM INSERTER IS FUSED TO THE MODULAR HANDLE AND WILL NOT COME APART. THIS DID NOT CAUSE ANY DELAY IN THE SURGERY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8382931 ↗
• MalfunctionMay 15, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE INSPECTING INSERTER HANDLES, IT WAS NOTICED THAT THE HANDLE AND STEM INSERTER WERE STUCK TOGETHER. WILL NOT COME PART. IT WAS ALSO INDICATED THAT WHILE INSPECTING INSERTER, IT WAS NOTICED THAT THE INSERTER WILL NOT FIT INTO HANDLE. THEY TRIED DIFFERENT HANDLES AND THE SAME PROBLEM EXISTS. IT WAS ALSO REPORTED THAT THE OFFSET REAMER WILL NOT FIT INSIDE THE OUTER REAMER PART. VERY DIFFICULT TO GET TOGETHER." NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513786 ↗
• MalfunctionMay 15, 2018Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT WHILE INSPECTING INSERTER HANDLES, IT WAS NOTICED THAT THE HANDLE AND STEM INSERTER WERE STUCK TOGETHER. WILL NOT COME PART. IT WAS ALSO INDICATED THAT WHILE INSPECTING INSERTER, IT WAS NOTICED THAT THE INSERTER WILL NOT FIT INTO HANDLE. THEY TRIED DIFFERENT HANDLES AND THE SAME PROBLEM EXISTS. IT WAS ALSO REPORTED THAT THE OFFSET REAMER WILL NOT FIT INSIDE THE OUTER REAMER PART. VERY DIFFICULT TO GET TOGETHER." NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7513773 ↗