PINNACLE 2217-50-006Recalls & reported problems
Depuy (Ireland) · PINNACLE POLY IMPACTOR TIP 28mm · Class 1
All models of PINNACLE (198)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
Quick summary
This DePuy Pinnacle Poly Impactor Tip is a surgical instrument tip used to seat hip replacement cups. The 34 reports mostly describe worn, scratched, bent or broken parts, cross-threaded and stripped threads on impactor tips and handles, and sleeves detaching from the tip. All 34 are malfunctions, with no deaths and no injuries, and most mention no effect on the patient. No recalls name this device.
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
- 34
- Deaths reported
- 0
- Injuries reported
- 0
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295098959), received between Mar 23, 2018 and Oct 15, 2025 — classified as 34 malfunctions.
The most frequently reported specific device problem is “Naturally Worn” (14 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.
Reports received per month
Most reported problems
Device problems
- Naturally Worn14
- Scratched Material13
- Material Deformation7
- Material Twisted/Bent6
- Break5
- Device-Device Incompatibility3
- Crack2
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- No Clinical Signs, Symptoms or Conditions25
- No Consequences Or Impact To Patient6
- Insufficient Information2
- No Known Impact Or Consequence To Patient1
Recent adverse event reports
The 25 most recent of 34 reports, in the reporter's own words as published by the FDA.
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 23303550 ↗MalfunctionDec 23, 2024Break; Break
IT WAS REPORTED THAT ON DECEMBER 10, 2024, A 28MM HEAD PUSHER HAD CHUNKS OUT OF IT. CSSD WOULD NOT ACCEPT IT FOR CLEANING. THERE WAS NO PATIENT INVOLVEMENT.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 21006299 ↗MalfunctionNov 20, 2024Break; Break
IT WAS REPORTED THAT THE FORCEPS BROKE AND 28 INSERTER IS CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20740136 ↗MalfunctionNov 20, 2024Break; Break
IT WAS REPORTED THAT THE FORCEPS BROKE AND 28 INSERTER IS CROSS THREADED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 20737519 ↗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 20180262 ↗MalfunctionAug 8, 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 19937468 ↗MalfunctionJun 25, 2024Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THE PRODUCT WAS NO LONGER IN CONDITION TO USE DUE TO WEAR OVERTIME.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 19606091 ↗MalfunctionFeb 17, 2023Naturally Worn; Naturally Worn
IT WAS REPORTED THAT THREADS ON IMPACTOR HANDLE AND IMPACTOR TIP WERE STRIPPED WHEN THREADING IMPACTOR TIP ONTO HANDLE AND USING TO INSERT CUP. THERE WAS NO REPORTED SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16396269 ↗MalfunctionJan 19, 2023Naturally Worn; Illegible Information; Naturally Worn; Illegible Information
ADDITIONAL INFORMATION RECEIVED. INDICATED, THAT THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16205513 ↗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 16089142 ↗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 16089107 ↗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 16089040 ↗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 16085604 ↗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 16085601 ↗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 16085553 ↗MalfunctionDec 19, 2022Material Integrity Problem; Material Integrity Problem
IT WAS REPORTED THAT THE LINER IMPACTOR TIP IS DAMAGED. THERE WAS NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 16006061 ↗MalfunctionOct 6, 2022Crack; Device-Device Incompatibility; Naturally Worn; Crack; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE IMPACTORS WERE WORN AND CRACKING. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15554147 ↗MalfunctionOct 6, 2022Crack; Device-Device Incompatibility; Naturally Worn; Crack; Device-Device Incompatibility; Naturally Worn
IT WAS REPORTED THAT THE IMPACTORS WERE WORN AND CRACKING. NO SURGICAL DELAY WAS REPORTED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 15553852 ↗MalfunctionApr 1, 2022Naturally Worn; Naturally Worn
CALCAR PLANAR INSTRUMENT BECOME EXTREMELY DULL AND UNUSABLE. NO REPORTED SURGICAL DELAY OR PATIENT CONSEQUENCES.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13975091 ↗MalfunctionMar 2, 2022Break; Break
IT WAS REPORTED THAT ON (B)(6) 2022, THE PATIENT UNDERWENT THE THA SURGERY FOR OA WITH THE LINER TRIAL AND THE IMPACTOR TIP IN QUESTION. IN THE SURGERY, A GREEN FRAGMENT WAS FOUND DURING THE IMPLANTATION OF THE LINER TRIAL. ONLY THE LINER TRIAL AND THE IMPACTOR TIP ARE GREEN INSTRUMENTS IN THIS SURGERY. SINCE THERE IS A CHIP IN THE TAB OF THE LINER TRIAL, IT IS SUSPECTED TO BE A BROKEN PIECE OF THIS PART, BUT AN INVESTIGATION IS REQUESTED TO CLARIFY WHERE THE BROKEN PIECE ORIGINATED. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHIN 30 MINUTES DELAY. NO FURTHER INFORMATION IS AVAILABLE.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 13652843 ↗MalfunctionJun 11, 2021Break; Material Twisted/Bent; Break; Material Twisted/Bent
IT WAS REPORTED THAT THE IMPACTOR TIP WORN, CHIPPED AND OLD. NEEDS REPLACEMENT. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11984650 ↗MalfunctionMay 26, 2021Material Twisted/Bent; Material Twisted/Bent
IT WAS REPORTED THAT THE INSTRUMENTS ARE TOO WORN FOR SURGERY. NO SURGICAL DELAY.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11891400 ↗MalfunctionFeb 3, 2021Scratched Material; Scratched Material
INSTRUMENTS WERE REPORTED AS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11274454 ↗MalfunctionFeb 3, 2021Scratched Material; Scratched Material
INSTRUMENTS WERE REPORTED AS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11274452 ↗MalfunctionFeb 3, 2021Scratched Material; Scratched Material
INSTRUMENTS WERE REPORTED AS SCUFFED.
Patient problems: No Clinical Signs, Symptoms or Conditions
MAUDE report 11274450 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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