PINNACLE 2218-36-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 73 adverse event reports that list this exact device (DI 10603295101192), received between Jul 21, 2017 and Apr 8, 2026 — classified as 73 malfunctions.

The most frequently reported specific device problem is “Break” (37 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 73 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 8, 2026Break

  IT WAS REPORTED THAT A PIECE CHIPPED OFF A POLY TRIAL INTRAOPERATIVELY. THE PIECE WAS RETRIEVED. THERE WAS NO EFFECT TO THE PATIENT OR SURGERY. IT IS UNKNOWN WHETHER THE SURGERY WAS DELAYED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24819634 ↗
• MalfunctionSep 18, 2025Break; Break

  IT WAS REPORTED THAT THE LINER TRIALS AND NECK SEGMENT ARE BROKEN. THERE WAS NO PATIENT CONSEQUENCE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23085937 ↗
• MalfunctionSep 9, 2025Break; Break

  IT WAS REPORTED THAT THE PRODUCT BROKE DURING TRIALING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23004326 ↗
• MalfunctionAug 20, 2025Device-Device Incompatibility; Material Deformation; Device-Device Incompatibility; Material Deformation

  IT WAS REPORTED THAT THE PINNACLE 36X52 NEUTRAL LINER IS STRIPPED NOT PROPERLY THREADING INTO/OUT OF CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22854792 ↗
• MalfunctionJun 18, 2025Material Deformation; Scratched Material; Material Deformation; 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. (B)(4) ARE RELATED TO EACH OTHER. THIS PC HAS BEEN CREATED TO CAPTURE ADDITIONAL IP'S FROM (B)(4).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22285718 ↗
• MalfunctionJun 17, 2025Material Deformation; Scratched Material; Material Deformation; 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 22236690 ↗
• MalfunctionFeb 25, 2025Crack; Crack

  IT WAS REPORTED THAT TRIAL LINERS WERE WORN/CRACKED. SCREWS ARE WORN AND CRACKS IN THE PLASTIC. THIS EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21462901 ↗
• MalfunctionOct 23, 2024Break; Break

  ADDITIONAL INFORMATION RECEIVED AND STATING THAT: A. WAS/WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? - NO ADVERSE EFFECTS. B. DID THE INSTRUMENT BREAK INTO TWO OR MORE PIECES? - IT WAS A CHIP AS STATED ORIGINALLY SO NEVER BROKE INTO PIECES. C. IF DEPUY SYNTHES INSTRUMENTATION BROKE DURING SURGERY, WERE ALL PIECES RETRIEVED FROM THE PATIENT? - IT WAS NOTICED BEFORE THEY USED IT. D. WAS SURGERY TIME EXTENDED DUE TO A DEPUY SYNTHES PRODUCT? IF YES, HOW LONG? - ALSO AS STATED ORIGINALLY NO TIME WAS ADDED ON.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 20513251 ↗
• MalfunctionSep 26, 2024Material Deformation; Scratched Material; Material Deformation; Scratched Material

  IT WAS REPORTED THAT DURING LOAN KIT INSPECTION, BY THE LOAN KIT TECHNICIAN, IT WAS IDENTIFIED THAT A POLY TRIAL HAD GOUGES AND SCRATCHES ALL OVER IT. THERE IS NO SURGEON, PROCEDURE, OR PATIENT DETAILS AVAILABLE. NO FURTHER INFORMATION CAN BE OBTAINED AS THE CASE WAS NOT REPORTED BY THE CUSTOMER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20315828 ↗
• MalfunctionSep 19, 2024Break; Break

  IT WAS REPORTED DURING A PROCEDURE ON (B)(6) 2024, THE 56N LINER TRIAL BOLT AND C RING FELL APART AFTER TRIALING. ALL PIECES WERE RETRIEVED FROM THE PATIENT.

  Patient problems: Insufficient Information

  MAUDE report 20262758 ↗
• MalfunctionAug 14, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  IT WAS REPORTED THAT THE LINER TRIAL WAS DAMAGED DURING A PROCEDURE. THE LINER WAS NOTED TO BE GOUGED AND SCARRED FROM WEAR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19981150 ↗
• MalfunctionJul 26, 2024Naturally Worn; Scratched Material; Naturally Worn; Scratched Material

  PINNACLE TRIAL LINERS REQUIRE REPLACEMENT DUE TO WEAR AND TEAR AND NOT PROPERLY SCREWING INTO THE TRIAL SHELL. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19843563 ↗
• MalfunctionJul 23, 2024Scratched Material; Scratched Material

  IT WAS REPORTED THAT THERE WERE SCRATCHES ON TRIALS. SURGICAL DELAY WAS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 19806032 ↗
• MalfunctionApr 8, 2024Break; Break

  IT WAS REPORTED THAT THERE WAS A BROKEN PINNACLE LINER TRIAL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19066583 ↗
• MalfunctionJan 30, 2024Material Discolored; Contamination /Decontamination Problem; Material Discolored; Contamination /Decontamination Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? NO. B. WERE THERE ANY ADVERSE CONSEQUENCES THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO. THE PRODUCT WAS NOT USED FOR SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18611037 ↗
• MalfunctionJan 8, 2024Device-Device Incompatibility; Naturally Worn; Illegible Information; Device-Device Incompatibility; Naturally Worn; Illegible Information

  IT WAS REPORTED THAT THE 36/56 NEUTRAL LINER WAS WORN, NOT THREADING INTO SHELL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18465348 ↗
• MalfunctionJun 12, 2023Material Integrity Problem; Material Integrity Problem

  IT WAS REPORTED THAT THE INSTRUMENTS WERE DAMAGED DURING STERILIZATION. IT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17105977 ↗
• 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 16087882 ↗
• 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 16087825 ↗
• 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 16087802 ↗
• 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 16087793 ↗
• 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 16087772 ↗
• 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 16087756 ↗
• 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 16087747 ↗
• 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 16087707 ↗