PINNACLE 2218-32-252Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 10603295100928), received between Oct 19, 2018 and Feb 15, 2024 — classified as 8 malfunctions.

The most frequently reported specific device problem is “Crack” (2 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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 15, 2024Crack; Crack

  TRIAL LINER HAS A SPLIT, ITEMS NOT IN PIECES. SPLIT NOTICED AFTER STERILIZING, ITEM NOT USED ON PATIENT. NO DELAY TO SURGERY, NO IMPACT ON PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18714246 ↗
• MalfunctionJun 26, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT TRIAL LINER IS BROKEN AND COULD GENERATE FRAGMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17199310 ↗
• MalfunctionJan 18, 2023Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE LINER THREADS ARE STRIPPED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16196641 ↗
• MalfunctionApr 28, 2021Scratched Material; Scratched Material

  NOTIFIED BY CSSD OF SCRATCHED PINNACLE LINER TRIALS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11739697 ↗
• MalfunctionApr 7, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT ON (B)(6) 2021, THE PATIENT UNDERWENT THE SURGERY VIA THA FOR RIGHT OA WITH THE LINER TRIAL IN QUESTION. DURING THE SURGERY, AFTER THE SURGEON USED THE LINER TRIAL, WHEN HE TRIED TO REMOVE IT WITH A SCREWDRIVER, THE LINER TRIAL COULDN¿T BE REMOVED. HE TURNED THE SCREW PART OF THE LINER TRIAL, AND IT WAS FOUND THAT THE RING PART OF THE LINER TRIAL CAME OFF AND THE LINER TRIAL WAS TAKEN APART. THE SURGEON USED THE LINER TRIAL IN NORMAL WAY. THE SURGERY WAS COMPLETED SUCCESSFULLY WITHOUT ANY SURGICAL DELAY. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11630378 ↗
• MalfunctionDec 15, 2020Contamination /Decontamination Problem; Scratched Material; Contamination /Decontamination Problem; Scratched Material

  THE LINER TRIALS ARE DAMAGED. 221832052 IS BROKEN ON THE RIM AS WELL AS MISSING THE CONNECTING SCREW. 221832252 IS SCRATCH AND HARDER TO CLEAN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11012953 ↗
• MalfunctionFeb 1, 2019Crack; Crack

  PRODUCT HAVING SLICE THROUGH EDGE. THIS WAS DISCOVERED DURING THEIR CLEANING PROCEDURES.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8298400 ↗
• MalfunctionOct 19, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  EDGE OF REAMER ABRADED THE EDGE OF THE LINER TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7985148 ↗