PINNACLE 2218-32-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 32 adverse event reports that list this exact device (DI 10603295100744), received between Jan 26, 2018 and Mar 26, 2026 — classified as 32 malfunctions.

The most frequently reported specific device problem is “Break” (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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 32 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 26, 2026No Apparent Adverse Event

  IT WAS REPORTED THAT THE IMPACTED PRODUCTS HAD AN UNKNOWN ALLEGATION. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24699889 ↗
• MalfunctionMar 5, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT THE TRIAL LINER'S SCREW METAL PIECE WAS DISENGAGED FROM PLASTIC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24524513 ↗
• MalfunctionJun 18, 2025Device-Device Incompatibility; Scratched Material; Device-Device Incompatibility; Scratched Material

  IT WAS REPORTED SEVERAL PINNACLE TRIAL LINERS HAVE BEEN SCRATCHED DUE TO WEAR AND TEAR, AS WELL AS NO LONGER THREADING PROPERLY INTO THE TRIAL SHELL. NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285309 ↗
• 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 22236290 ↗
• MalfunctionOct 12, 2023Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  ROUTINE INSPECTION OF INSTRUMENTS. OPENED 4 DIFFERENT SETS OF TRAYS TO INSPECT ITEMS. MULTIPLE ITEMS WITH SCRATCHES AND WEAR AND TEAR REQUIRING REPLACEMENT. THERE WAS NO PATIENT CONSEQUENCE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17920193 ↗
• MalfunctionJan 3, 2023Break; Break

  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 16087374 ↗
• MalfunctionJan 3, 2023Break; Break

  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 16087360 ↗
• MalfunctionJan 3, 2023Break; Break

  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 16087352 ↗
• MalfunctionJan 3, 2023Break; Break

  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 16087334 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  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 16087245 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  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 16087237 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  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 16087207 ↗
• MalfunctionJan 3, 2023Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  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 16087183 ↗
• 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 15614679 ↗
• 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 15614658 ↗
• 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 15614595 ↗
• 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 15614581 ↗
• 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 15614545 ↗
• MalfunctionJan 5, 2021Break; Detachment of Device or Device Component; Break; Detachment of Device or Device Component

  THE SCREW BECAME DISENGAGED FROM THE LINER TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11118687 ↗
• MalfunctionAug 26, 2020Material Twisted/Bent; Scratched Material; Material Twisted/Bent; Scratched Material

  MDR STAFF REPORTED 6 WORN AND DISCOLOURED GARTER SHAFT COVERS. PRODUCTS ARE OLD AND WORN AND REQUIRE REPLACEMENT. STAFF ALSO REPORTED WORN AND GOUGED 32MM PINNACLE LINER TRIALS.

  Patient problems: No Code Available; No Consequences Or Impact To Patient

  MAUDE report 10457773 ↗
• MalfunctionMar 19, 2020Break; Break

  IT WAS REPORTED THAT THERE WERE TRIAL WAS BEING CONDUCTED, PIECES WERE CHIPPED AND BROKEN DURING EXPLANT OF CUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9853142 ↗
• MalfunctionJun 5, 2019Break; Material Disintegration; Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent; Break; Material Disintegration; Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent

  IT SEEMS AS THOUGH IT IS LOOSE AND THERE IS A LOT OF PLAY. NOT BENT OR CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671814 ↗
• MalfunctionJun 5, 2019Break; Material Disintegration; Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent; Break; Material Disintegration; Loose or Intermittent Connection; Device-Device Incompatibility; Material Twisted/Bent

  IT SEEMS AS THOUGH IT IS LOOSE AND THERE IS A LOT OF PLAY. NOT BENT OR CRACKED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8671813 ↗
• MalfunctionMar 29, 2019Material Deformation; Naturally Worn; Material Deformation; Naturally Worn

  IT WAS REPORTED THAT THE 32X56 NEUTRAL LINER WAS WORN AND HAS NUMEROUS SCRAPES AND SCRATCHES. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8464458 ↗
• MalfunctionNov 16, 2018Break; Break

  TRIAL BROKE FROM THE RIM.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8077924 ↗