PINNACLE 2217-50-008Recalls & reported problems

Summary

The FDA's MAUDE database contains 108 adverse event reports that list this exact device (DI 10603295098973), received between Aug 31, 2017 and Sep 14, 2026 — classified as 108 malfunctions.

The most frequently reported specific device problem is “Break” (41 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 108 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 14, 2026Material Deformation

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50755415 ↗
• MalfunctionMay 6, 2026Device-Device Incompatibility

  ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093521 ↗
• MalfunctionMay 6, 2026Device-Device Incompatibility

  ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093519 ↗
• MalfunctionMay 6, 2026Device-Device Incompatibility

  ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093516 ↗
• MalfunctionMay 6, 2026Device-Device Incompatibility

  ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093509 ↗
• MalfunctionMay 6, 2026Device-Device Incompatibility

  ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY. TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. THERE WAS NO REPORTED PATIENT OR USER HARM. THERE WAS NO SIGNIFICANT DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25093508 ↗
• MalfunctionMay 5, 2026Device-Device Incompatibility

  IT WAS REPORTED THAT ALL EQUIPMENT PANS HAVE BECOME CRACKED THROUGH REGULAR USE. THE IMPACTOR TIPS NO LONGER CONNECT SMOOTHLY, AND THE TRIAL SHELLS NO LONGER THREAD TOGETHER SMOOTHLY. IT WAS REPORTED THAT THERE WAS NO SIGNIFICANT DELAY, AND NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25085029 ↗
• MalfunctionApr 15, 2026Break

  IT WAS REPORTED THAT DURING IMPACTION OF THE LINER, THE 36MM LINER IMPACTOR BROKE INTO 3 PIECES. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO DELAY. NO ADDITIONAL INFORMATION WAS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24889349 ↗
• MalfunctionApr 2, 2026Break

  IT WAS REPORTED THAT 36MM POLY IMPACTOR TIP HAD 2 PIECES BREAK OFF WHILE IMPACTING A LINER INTO PLACE. ALL PIECES WERE RETRIEVED AND SURGICAL TIME WAS NOT EXTENDED. NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24767824 ↗
• MalfunctionMar 4, 2026Break

  IT WAS REPORTED THAT DURING TOTAL HIP SURGERY, ONE INSTRUMENT BROKE DURING CASE. THEY HAD BACKUPS SO THERE WERE NO DELAYS TO SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24507957 ↗
• MalfunctionFeb 25, 2026Break

  IT WAS REPORTED THAT THE INSTRUMENTS WERE BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24443002 ↗
• MalfunctionFeb 18, 2026Break; Contamination /Decontamination Problem

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT SURGERY, IT WAS OBSERVED THAT THE IMPACTOR HAD METAL PIECES EMBEDDED INTO IT. THE STERILE PROCESSING DEPARTMENT (SPD) REQUESTED IT BE REPLACED IMMEDIATELY. NO DELAYS, NOTHING LEFT IN PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24377569 ↗
• MalfunctionFeb 3, 2026Crack; Material Deformation

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246563 ↗
• MalfunctionFeb 3, 2026Crack; Material Deformation

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246562 ↗
• MalfunctionFeb 3, 2026Crack; Material Deformation

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246561 ↗
• MalfunctionFeb 3, 2026Crack; Material Deformation

  IT WAS REPORTED THAT SEVERAL INSTRUMENTS HAVE BEEN DEEMED NO LONGER USABLE DUE TO BEING CRACKED, CROSS THREADED WITH WEAR AND TEAR OVER TIME.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24246556 ↗
• 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 24221227 ↗
• 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 24221203 ↗
• MalfunctionDec 18, 2025Break; Break

  IT WAS REPORTED THAT WHILE IMPACTING THE LINER, THE ORANGE 36MM TIP BROKE OFF THE METAL PIECE THAT SCREWS ON TO THE IMPACTOR HANDLE. NO DELAY. NO HARM TO PATIENT. NO ADDITIONAL INFORMATION IS AVAILABLE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23843370 ↗
• MalfunctionDec 4, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT DURING A TOTAL HIP REPLACEMENT, A GOUGE WAS FOUND ON THE HEAD OF THE PINN POLY IMPACTOR TIP AND THE DEVICE WAS NOT USED. THERE WAS NO PATIENT HARM, NO PROCEDURAL DELAY, AND NO PART OF THE IMPACTOR BROKE OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23717663 ↗
• MalfunctionNov 18, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT POLY IMPACTOR TIP WAS DENTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23586887 ↗
• MalfunctionOct 15, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT THE MEDICAL DEVICE REPROCESSING STAFF NOTICED THAT THE PINNACLE CUP INSERTER THREADS WERE CROSS THREADED, AND ALL THREE SIZES OF THE IMPACTOR TIPS WERE ALSO CROSS THREADED AND SO WAS THE DURALOC IMPACTOR HANDLE. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23303694 ↗
• MalfunctionApr 24, 2025Break; Break

  IT WAS REPORTED THAT THE T-HANDLE FORMED A CRACK IN THE PLASTIC PORTION WHILE REAMING FOR A FEMORAL STEM. NO PIECES BROKE OFF AND SURGICAL TIME WAS NOT EXTENDED. NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED. IN ADDITION TO THIS, A PIECE OF A 36MM (ORANGE) LINER IMPACTOR TIP BROKE OFF WHILE IMPACTING AN ALTRX LINER INTO A PINNACLE CUP. ALL PIECES WERE RETRIEVED, SURGICAL TIME WAS NOT EXTENDED, AND NO ADVERSE CONSEQUENCES FOR THE PATIENT OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21903539 ↗
• MalfunctionJan 27, 2025Break; Break

  IT WAS REPORTED THAT THE METAL PART OF THE 36MM ORANGE LINER IMPACTOR BECAME DISENGAGED. THERE WAS NO SURGICAL DELAY AND NO ADVERSE PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21241901 ↗
• MalfunctionDec 11, 2024Break; Unintended Movement; Break; Unintended Movement

  IT WAS REPORTED THAT IMPACTOR TIP BECAME LOOSE. THE INTERNAL METAL SECTION BECAME LOOSE AND THE ITEM BROKE INTO TWO PARTS. THERE WAS NO PATIENT CONSEQUENCE AND NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20905592 ↗