PINNACLE 2218-87-356Recalls & reported problems

Summary

The FDA's MAUDE database contains 12 adverse event reports that list this exact device (DI 10603295101932), received between Nov 5, 2018 and Nov 5, 2025 — classified as 12 malfunctions.

The most frequently reported specific device problem is “Break” (5 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 12 most recent of 12 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 5, 2025Break; Break

  IT WAS REPORTED THAT AT THE TIME OF TESTING THE INSERT IS BROKEN. ALL PARTICLES ARE REMOVED, AND ANOTHER TEST INSERT IS PASSED TO SOLVE AT THE MOMENT AND THIS IS BROKEN THE EDGE. THERE WAS NO AFFECTATION TO THE PATIENT. ALL THE PARTICLES CAME OUT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23477904 ↗
• MalfunctionDec 28, 2022Break; Break

  IT WAS REPORTED THAT THE 56MM AB LINER TRIAL BROKE DURING IMPACTION. ALL PIECES WERE RECOVERED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16062516 ↗
• MalfunctionDec 12, 2022Break; Break

  HIP REVISION: THE SURGEON WAS TRIALING WITH THE AB 56/36MM TRIAL INTO THE GRIPTION ACETABULAR CUP (RELOCATED AND TOOK THE LEG THROUGH A ROM), AND WHEN THEY REMOVED THE TRIAL FROM THE ACETABULUM THEY NOTICED IT HAD COME APART ON THE MAYO TABLE. SALINE WAS USED IN THE PATIENT WITH SUCTION TO CLEAN ANY DEBRIS. SURGEON WAS HAPPY. WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? NO. WAS PROCEDURE SUCCESSFULLY COMPLETED? YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15962170 ↗
• MalfunctionJun 15, 2022Break; Break

  IT WAS REPORTED THAT THE PINNACLE 36 X 56 TEST INSERT BROKE. IT HAS NO NEGATIVE INVOLVEMENT IN THE PATIENT. THIS IS WHY THERE WAS A DELAY DURING THE PROCEDURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14695385 ↗
• MalfunctionApr 27, 2021Scratched Material; Scratched Material

  IT HAS BEEN BROUGHT TO MY ATTENTION BY MDRD THAT TOTAL 5 OF OUR 36MM TRIAL LINERS HAVE SUFFERED SOME WEAR AND TEAR. THERE ARE GOUGES IN THE MATERIAL AND THEREFORE SITE WILL NOT STERILIZE AND REPROCESS THESE TRIAL LINERS. THREE OF THE LINERS ARE DOWNSTAIRS AND WILL HAVE TO CONFIRM WHICH THREE THOSE ARE. AS FOR THE MISSING OTHER 2 THE LEAD OF MDRD IS CERTAIN THEY GAVE THEM TO ONE OF OUR SALES TEAMMATES BUT HAVE NOT BEEN ABLE TO LOCATE THEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11732169 ↗
• MalfunctionFeb 18, 2021Crack; Crack

  TRIAL LINER CRACKED WHILE USING EXTRACTION TOOL.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11345151 ↗
• MalfunctionFeb 16, 2021Scratched Material; Scratched Material

  LINER TRIALS WERE FOUND TO HAVE DEEP GOUGES THAT WERE HARD TO CLEAN AND WERE REJECTED BY THE MEDICAL DEVICE REPROCESSING DEPARTMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11334658 ↗
• MalfunctionJan 23, 2020Break; Break

  THIS INSTRUMENT WAS FOUND BROKEN BY MDR.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9621589 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038081 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038067 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8038066 ↗
• MalfunctionNov 5, 2018Naturally Worn; Naturally Worn

  TRIALS ARE WORN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8037757 ↗