PINNACLE 2218-28-048Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295100195), received between Mar 2, 2018 and Jun 17, 2025 — classified as 23 malfunctions.

The most frequently reported specific device problem is “Crack” (8 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 18, 2026.

Most reported problems

Recent adverse event reports

The 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• MalfunctionJun 17, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THE PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR; THEY ALSO NO LONGER THREAD PROPERLY INTO THE TRIAL SHELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236126 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THE PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR; THEY ALSO NO LONGER THREAD PROPERLY INTO THE TRIAL SHELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236114 ↗
• MalfunctionJun 17, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED THE PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR; THEY ALSO NO LONGER THREAD PROPERLY INTO THE TRIAL SHELL. THERE WERE NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22236107 ↗
• MalfunctionAug 15, 2024Break; Break

  THIS INSTRUMENT IS COMPOSED OF 1 PART. THE INSTRUMENT CONTAINS A CRACK. THE PRODUCT DAMAGE DOCUMENTED IN THIS PC HAS BEEN IDENTIFIED DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN. THE EVENT DATE AND ALERT DATE ARE THE DATE THAT THE INSPECTION TOOK PLACE. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE.

  Patient problems: Insufficient Information

  MAUDE report 19990659 ↗
• MalfunctionOct 4, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  THE BOLT FELL OUT OF THE 28X48 N LINER TRIAL, RETAINING RING FELL OUT OF THE STD CORAIL NECK SEGMENT. THE SURGERY WASN'T DELAYED.

  Patient problems: Insufficient Information

  MAUDE report 17867724 ↗
• MalfunctionJan 3, 2023Crack; Crack

  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 16085695 ↗
• MalfunctionJan 3, 2023Crack; Crack

  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 16085665 ↗
• MalfunctionJan 3, 2023Crack; Crack

  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 16085659 ↗
• MalfunctionJan 3, 2023Crack; Crack

  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 16085655 ↗
• MalfunctionJan 3, 2023Crack; Crack

  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 16085649 ↗
• MalfunctionJan 3, 2023Crack; Crack

  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 16085636 ↗
• MalfunctionJan 3, 2023Crack; Crack

  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 16085633 ↗
• MalfunctionJan 3, 2023Crack; Crack

  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 16085623 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616824 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616731 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616613 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616510 ↗
• MalfunctionOct 17, 2022Contamination /Decontamination Problem; Contamination /Decontamination Problem

  IT WAS REPORTED THAT THERE IS A GREEN RESIDUE ON THE TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15616411 ↗
• MalfunctionSep 6, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE INNER METAL SCREW FELL OUT OF LINER TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15361031 ↗
• MalfunctionMar 24, 2021Material Twisted/Bent; Unintended Movement; Material Twisted/Bent; Unintended Movement

  SURGEON INDICATED NEUTRAL 28/48 TRIAL LINER WAS LOOSE AND WORN DUE TO WEAR AND TEAR. NO SURGICAL DELAY OR PATIENT ISSUES. SURGERY WAS COMPLETED SUCCESSFULLY. ITEM HAS BEEN DISCARDED. NO ADDITIONAL INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11562797 ↗
• MalfunctionOct 10, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  MDR HAS INDICATED A PINNACLE NEUTRAL TRIAL LINER (28/48) HAS BEEN DISCARDED DUE TO WEAR AND TEAR AND NEEDS TO BE REPLACED. PRODUCT IS NO LONGER FUNCTIONAL AND REPLACEMENT IS REQUIRED. NOT INTRA-OP AND THEREFORE NO PATIENT ISSUES. NO SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9175662 ↗
• MalfunctionMay 18, 2018Material Deformation; Scratched Material; Insufficient Device Problem Information; Material Deformation; Scratched Material; Insufficient Device Problem Information

  MEDICAL DEVICE REPROCESSING STAFF IDENTIFIED THAT ITEM 221828048 (28/48 NEUTRAL TRIAL LINER) WAS DAMAGED AND NO LONGER FUNCTIONAL. THE ITEM WAS DISCARDED AND A REPLACEMENT IS REQUIRED. NO FURTHER INFORMATION IS AVAILABLE. PLEASE SEND REPLACEMENT ITEM DIRECT TO CUSTOMER AT (B)(6). THANK YOU. PATIENT CONSEQUENCE? NO. IS THE INFORMATION BEING SUBMITTED FOR THIS COMPLAINT ALL THE DETAILS THAT ARE KNOWN/AVAILABLE REGARDING THIS EVENT? YES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7527281 ↗
• MalfunctionMar 2, 2018Break; Break

  IT WAS REPORTED A TRIAL WAS FOUND TO BE DAMAGED UPON INSPECTION IN CENTRAL STERILE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7310314 ↗