PINNACLE 2217-50-007Recalls & reported problems
Depuy (Ireland) · PINNACLE POLY IMPACTOR TIP 32mm · Class 1
Quick summary
This DePuy Pinnacle 32mm Poly Impactor Tip is a surgical instrument used to seat hip implant components. The 50 reports describe instruments wearing out with normal use — cracking, scratching, deforming and breaking, and tips and trial shells that no longer connect or thread smoothly. No deaths and no injuries were reported; most mentions note no effect on the patient. There are no recalls naming this device. Reports rose from 2 in the prior 12 months to 11 in the most recent 12 months.
AI-generated from the FDA records on this page and checked automatically against the numbers below. Read the details before relying on it.
- Adverse event reports
- 49
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 49 adverse event reports that list this exact device (DI 10603295098966), received between Jan 26, 2018 and May 6, 2026 — classified as 49 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (22 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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Naturally Worn22
- Scratched Material17
- Material Deformation16
- Crack9
- Device-Device Incompatibility8
- Break7
- Material Twisted/Bent4
- Unintended Movement2
Patient problems
- No Clinical Signs, Symptoms or Conditions31
- No Consequences Or Impact To Patient12
- Insufficient Information6
Recent adverse event reports
The 25 most recent of 49 reports, in the reporter's own words as published by the FDA.
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 25093522 ↗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 25093514 ↗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 25093513 ↗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 25093510 ↗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 25084911 ↗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 24246491 ↗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 24246490 ↗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. THESE INSTRUMENTS DO GET REPLACED EVERY SO OFTEN DUE TO USAGE OVER TIME AS MENTIONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246367 ↗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. THESE INSTRUMENTS DO GET REPLACED EVERY SO OFTEN DUE TO USAGE OVER TIME AS MENTIONED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 24246364 ↗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 24221179 ↗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 23304123 ↗MalfunctionJul 16, 2025Break; Break
IT WAS REPORTED THAT THE ITEM WAS BROKEN AMD NEEDS REPLACING. THERE WERE NO PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 22521049 ↗MalfunctionOct 30, 2024Contamination /Decontamination Problem; Material Deformation; Naturally Worn; Contamination /Decontamination Problem; Material Deformation; Naturally Worn
IT WAS REPORTED THAT A PATIENT UNDERWENT A TOTAL HIP REPLACEMENT SURGERY ON (B)(6) 2024. THE THREADS ON THE IMPACTOR TIP HAVE WORN DOWN AND CAN NO LONGER BE PROPERLY CLEANED. NO FURTHER DETAILS WERE PROVIDED.
Patient problems: Insufficient Information
MAUDE report 20566371 ↗MalfunctionSep 10, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE 28 AND 32 IMPACTOR TIP THREADS ARE BAD.
Patient problems: Insufficient Information
MAUDE report 20180288 ↗MalfunctionAug 9, 2024Device-Device Incompatibility; Unintended Movement; Device-Device Incompatibility; Unintended Movement
IT WAS REPORTED THAT THE IMPACTORS NOT USED FOR THE CASE BUT THE SLEEVES OF THE IMPACTOR TIPS ARE LOOSE AND EASILY DETACH FROM THE TIP.
Patient problems: Insufficient Information
MAUDE report 19947861 ↗MalfunctionJul 19, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT WORN DAMAGE TO TWO 32 BLUE IMPACTOR HEADS FOR LINER IMPACTION. NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 17353691 ↗MalfunctionJul 19, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT WORN DAMAGE TO TWO 32 BLUE IMPACTOR HEADS FOR LINER IMPACTION. NO SURGICAL DELAY.
Patient problems: Insufficient Information
MAUDE report 17353654 ↗MalfunctionApr 4, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material
IT WAS REPORTED THAT TRIAL HEAD IS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16674913 ↗MalfunctionJan 5, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE TIP WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16108110 ↗MalfunctionJan 5, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16107025 ↗MalfunctionJan 5, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
IT WAS REPORTED THAT THE INSTRUMENT WAS DAMAGED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16106949 ↗MalfunctionJan 3, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED, AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16089050 ↗MalfunctionJan 3, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088994 ↗MalfunctionJan 3, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
ALL 28/32/36MM LINER TRIALS REQUIRE REPLACEMENT DUE TO BEING CRACKED, CROSS THREADED, DISCOLOURED, AND CHIPPED. THEY ARE NO LONGER USABLE WITH THE SCREWDRIVER AND THEREFORE DO NOT SCREW IN PROPERLY TO THE TRIAL CUP. THESE LINER TRIALS ARE IN ROUGH SHAPE DUE TO SEVERAL YEARS OF USE/WEAR AND TEAR. NO REPORTED PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16088965 ↗MalfunctionJan 3, 2023Material Deformation; Naturally Worn; Scratched Material; Material Deformation; Naturally Worn; Scratched Material
THE 28 AND 32MM LINER IMPACTOR TIPS ARE BURRED AND SCRATCHED UP DUE TO WEAR AND TEAR. THE HEX LINER SCREWDRIVERS ARE STRIPPED ON THE BOTTOM AND HAVE WORN DOWN OVER TIME. THEY NO LONGER CONNECT INTO THE TRIAL LINER. THE PINNACLE STRAIGHT CUP INSERTERS HAVE BROKEN OFF STRIKE PLATES ON THE PROXIMAL END OF THE INSTRUMENT. THEY CAN NO LONGER IMPACT PINNACLE CUPS. THE STANDARD AND HIGH OFFSET NECK TRIALS ARE BURRED ON THE INSIDE AND NO LONGER CONNECT PROPERLY TO A TRIAL BROACH. THERE WERE NO PATIENT CONSEQUENCES. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16085616 ↗
Other IMPACTOR devices
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- ATTUNE 2544-01-006Depuy (Ireland) · IMPACTOR1 recall2,539 reports
- ATTUNE 2544-01-003Depuy (Ireland) · IMPACTOR1 recall1,498 reports
- ATTUNE 2544-01-017Depuy (Ireland) · IMPACTOR1 recall1,456 reports
- ATTUNE 2544-01-004Depuy (Ireland) · IMPACTOR1 recall875 reports
- DURALOC 2360-71-000Depuy Orthopaedics, Inc. · IMPACTOR716 reports
- SPECIALIST 2581-11-000Depuy (Ireland) · IMPACTOR704 reports
- INHANCE 6205-10-103Depuy (Ireland) · IMPACTOR337 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.