PINNACLE 2218-28-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295100201), received between Oct 10, 2018 and Apr 23, 2026 — classified as 20 malfunctions.

The most frequently reported specific device problem is “Break” (10 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• MalfunctionApr 23, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING AN UNSPECIFIED SURGICAL PROCEDURE IT WAS OBSERVED THAT THE SCREW MECHANISM HAS COME LOSE FROM THE TRIAL. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24971863 ↗
• 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 22236258 ↗
• 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 22236233 ↗
• 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 22236213 ↗
• 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 17920202 ↗
• 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 16086970 ↗
• 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 16086956 ↗
• 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 16086948 ↗
• 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16086921 ↗
• 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 16086839 ↗
• 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 16086815 ↗
• 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 16086765 ↗
• MalfunctionDec 29, 2022Break; Crack; Material Discolored; Naturally Worn; Break; Crack; Material Discolored; Naturally Worn

  STAFF HAVE INDICATED SEVERAL CORAIL PINNACLE INSTRUMENTS REQUIRE REPLACEMENT. 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 FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16075154 ↗
• 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 15617437 ↗
• 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 15616929 ↗
• 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 15616527 ↗
• 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 15616406 ↗
• 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 15615750 ↗
• MalfunctionJun 20, 2019Break; Scratched Material; Break; Scratched Material

  IT WAS REPORTED THAT THIS PATIENT'S HIP WAS REVISED DUE TO DISLOCATION. EVEN THOUGH THIS PATIENT HAD A PINNACLE CONSTRAINED LINER FROM A PREVIOUS HIP REVISION SURGERY, AND THE LINER AND LOCKING RING WERE STILL IN PLACE, SHE STILL MANAGED TO SOMEHOW DISLOCATE HER HIP AGAIN. HER PRIOR SURGERY WAS ALSO DUE TO DISLOCATION. THIS TIME, IT APPEARED THAT HER HIP HAD DISLOCATED POSTERIORLY, ACCORDING TO DR. (B)(6), THE ORTHOPAEDIC FELLOW WHO ASSISTED THE SURGEON DURING THIS PROCEDURE. THE SURGEON SEEMED TO THINK THAT THE PATIENT'S HIP DISLOCATED DUE TO POSSIBLE IMPINGEMENT OR BECAUSE THE POSITION OF HER ACETABULAR CUP APPEARED TO BE SLIGHTLY RETROVERTED. THE PATIENT'S FEMORAL HEAD AND CONSTRAINED LINER WERE REMOVED, AND REPLACED BY A COMPETITOR CUP AND A DEPUY BIOLOX DELTA TS CERAMIC REVISION FEMORAL HEAD, 28MM +12, 12/14 TAPER. ALSO DURING THIS PROCEDURE, A PLASTIC PINNACLE TRIAL LINER BROKE INTO TWO PIECES AS SURGEON WAS ATTEMPTING TO SCREW IT INTO THE PATIENT'S PINNACLE ACETABULAR CUP. THE TRIAL WAS USED IN CONJUNCTION WITH THE COMPETITOR EXPLANT SYSTEM TO REMOVE THE PINNACLE CUP IMPLANT. BOTH PIECES OF THE TRAIL WERE RETRIEVED AND THE CASE WAS ONLY DELAYED APPROXIMATELY TWO MINUTES, WHI

  Patient problems: Not Applicable

  MAUDE report 8717865 ↗
• MalfunctionOct 10, 2018Break; Break

  POLY TRIALS ARE SCRAPED AND CHIPPED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7952923 ↗