NA 2598-07-460Recalls & reported problems

Summary

The FDA's MAUDE database contains 153 adverse event reports that list this exact device (DI 10603295148449), received between Aug 1, 2017 and Sep 22, 2026 — classified as 153 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (110 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 25 most recent of 153 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 22, 2026Device-Device Incompatibility; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50858523 ↗
• MalfunctionSep 16, 2026Device-Device Incompatibility; Mechanical Jam

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794054 ↗
• MalfunctionSep 16, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50794053 ↗
• MalfunctionSep 15, 2026Device-Device Incompatibility

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50781177 ↗
• MalfunctionJun 2, 2026Break

  IT WAS REPORTED THAT THE IMPACTED PRODUCT HAD AN UNKNOWN ALLEGATION. IT WAS FURTHER REPORTED THAT THE DEVICES WERE FOUND TO BE BROKEN PRIOR TO SHIPMENT. THE EVENT DID NOT OCCUR IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25360924 ↗
• MalfunctionMay 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE STEM INSERTED GOT STUCK IN THE MODULE HANDLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25159915 ↗
• MalfunctionMay 8, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT UNIVERSAL HANDLE AND CURVED STEM INSERTER WERE STUCK TOGETHER

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25123250 ↗
• MalfunctionApr 30, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGICAL PROCEDURE IT WAS OBSERVED THAT THE MODULAR HANDLE AND STEM IMPACTOR BECAME STUCK TOGETHER AND WERE UNABLE TO BE REMOVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25041639 ↗
• MalfunctionApr 21, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT CORAIL IMPACTOR HANDLE AND CURVED IMPACTION PIECE WERE STUCK TOGETHER. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24941933 ↗
• MalfunctionApr 13, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT THE UNIVERSAL HANDLE DOESN'T ALLOW FOR ANY INSERTER TO INSERT CORRECTLY - THE HOLE SEEMS TOO SMALL. ANOTHER SET WAS USED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24858567 ↗
• MalfunctionFeb 3, 2026Crack; Material Deformation

  IT WAS REPORTED THAT SEVERAL UNIVERSAL STEM INSERT HANDLE INSTRUMENTS WERE NO LONGER USABLE AFTER BEING FOUND CRACKED, CROSS THREADED, OR OTHERWISE WORN FROM NORMAL USE AND HAVE BEEN REPLACED PERIODICALLY DUE TO USAGE OVER TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247335 ↗
• MalfunctionFeb 3, 2026Crack; Material Deformation

  IT WAS REPORTED THAT SEVERAL UNIVERSAL STEM INSERT HANDLE INSTRUMENTS WERE NO LONGER USABLE AFTER BEING FOUND CRACKED, CROSS THREADED, OR OTHERWISE WORN FROM NORMAL USE AND HAVE BEEN REPLACED PERIODICALLY DUE TO USAGE OVER TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247330 ↗
• MalfunctionFeb 3, 2026Crack; Material Deformation

  IT WAS REPORTED THAT SEVERAL UNIVERSAL STEM INSERT HANDLE INSTRUMENTS WERE NO LONGER USABLE AFTER BEING FOUND CRACKED, CROSS THREADED, OR OTHERWISE WORN FROM NORMAL USE AND HAVE BEEN REPLACED PERIODICALLY DUE TO USAGE OVER TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247317 ↗
• MalfunctionFeb 3, 2026Crack; Material Deformation

  IT WAS REPORTED THAT SEVERAL UNIVERSAL STEM INSERT HANDLE INSTRUMENTS WERE NO LONGER USABLE AFTER BEING FOUND CRACKED, CROSS THREADED, OR OTHERWISE WORN FROM NORMAL USE AND HAVE BEEN REPLACED PERIODICALLY DUE TO USAGE OVER TIME. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24247304 ↗
• MalfunctionJan 30, 2026Crack; Material Deformation

  SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED ETC WITH WEAR AND TEAR OVER TIME. THESE INSTRUMENTS DO GET REPLACED EVERY SO OFTEN DUE TO USAGE OVER TIME AS MENTIONED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENTS DIRECT TO THE ACCOUNT: [REDACTED] [REDACTED] [REDACTED] [REDACTED] N/C PO: [REDACTED] BILL TO: [REDACTED] SHIP TO: [REDACTED] PINN STRAIGHT CUP IMPACTOR - 221750041 (221750041): NOT APPLICABLE DURALOC STR CUP IMPACTOR - 236071000 (236071000): NOT APPLICABLE PINN CUP IMPACTOR TIP 32MM - 221750007 (221750007): NOT APPLICABLE PINN POLY IMPACTOR TIP 36MM - 221750008 (221750008): NOT APPLICABLE QUICKSET EZ CLEAN GRATER HAND. - 979810000 (979810000): NOT APPLICABLE PINNACLE VERSION GUIDE - 221750044 (221750044): NOT APPLICABLE APEX HOLE ELIM TPD HEX DRIVER - 234601000 (234601000): NOT APPLICABLE SUMMIT UNIVERSAL BROACH HANDLE - 257000000 (257000000): NOT APPLICABLE UNIVERSAL STEM INSERT HANDLE - 259807460 (259807460): NOT APPLICABLE CALCAR MILL MEDIUM - 200148000 (200148000): NOT APPLICABLE MODULAR BOX OSTEOTOME - 259807530 (259807530): NOT APPLICABLE ARTICUL TR BALL GRVD 36-2 - 253150000 (253150000): NOT APPLICABLE ART

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24221273 ↗
• MalfunctionDec 24, 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 23888982 ↗
• MalfunctionDec 3, 2025Break; Break

  THIS IS REPORT 2 OF 2 FOR (B)(4). IT WAS REPORTED THAT THE INSERTER AND HANDLE BROKE UPON IMPACTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23706635 ↗
• MalfunctionNov 19, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE MODULAR STEM AND SERVE HANDLE WERE NOT ACCEPTING STEM TIPS. THE USER USED A CONCISE DEVICE. THERE WAS NO SURGICAL DELAY, THERE WAS NO PATIENT HARM AND NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23595436 ↗
• MalfunctionSep 10, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE PATIENT HAS A LEFT TOTAL HIP. THE 2 PIECE ACTIS STEM INSERTER WAS STUCK TOGETHER AND IT WOULD NOT SEPARATE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23014899 ↗
• MalfunctionAug 12, 2025Break; Break

  IT WAS REPORTED THAT THE IMPACTOR FITTING BROKEN DURING SURGERY. BROKE WHEN ONE PIECE FIT INTO ANOTHER. BOTH PIECES BROKEN INTO 2 PIECES. NO FRAGMENTS WERE GENERATED. A NEW INSTRUMENT WAS OPENED TO USE. THERE WAS A 5 MINUTES OF SURGICAL DELAY. THE PROCEDURE WAS SUCCESSFULLY COMPLETED. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22786547 ↗
• MalfunctionJul 31, 2025Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT, DURING SURGERY, THE HANDLE COULD NOT BE SEPARATED FROM THE IMPACTOR. THIS DID NOT CAUSE ANY DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22679628 ↗
• MalfunctionJul 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED DURING DEVICE REPROCESSING, STAFF NOTICED DEFECTS ON EQUIPMENT THAT PREVENTED THEM FROM BEING SAFE TO USE FOR PATIENTS. THE FEMORAL RASP WAS MISSING TEETH, THE CALCAR MILLS WERE DULL, THE FEMORAL HEAD IMPACTOR WAS CROSS THREADED AND THE CURVED BROACH HANDLE DID NOT CLOSE PROPERLY. NO PATIENT CONSEQUENCES. (B)(4) WHICH WAS CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554702 ↗
• MalfunctionJul 21, 2025Material Deformation; Material Deformation

  IT WAS REPORTED DURING DEVICE REPROCESSING, STAFF NOTICED DEFECTS ON EQUIPMENT THAT PREVENTED THEM FROM BEING SAFE TO USE FOR PATIENTS. THE FEMORAL RASP WAS MISSING TEETH, THE CALCAR MILLS WERE DULL, THE FEMORAL HEAD IMPACTOR WAS CROSS THREADED AND THE CURVED BROACH HANDLE DID NOT CLOSE PROPERLY. NO PATIENT CONSEQUENCES. (B)(4) IS RELATED TO (B)(4) WHICH WAS CREATED TO CAPTURE ADDITIONAL IMPACTED PRODUCTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22554376 ↗
• MalfunctionMar 19, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE LOCKING MECHANISM DOES NOT WANT TO LATCH TO THE INSERTION HANDLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645370 ↗
• MalfunctionMar 19, 2025Structural Problem; Structural Problem

  IT WAS REPORTED THAT THE LOCKING MECHANISM DOES NOT WANT TO LATCH TO THE INSERTION HANDLE. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21645368 ↗