PINNACLE 2218-40-456Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295101529), received between Mar 1, 2018 and Jan 2, 2025 — classified as 11 malfunctions.

The most frequently reported specific device problem is “Break” (8 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionJan 2, 2025Break; Break

  IT WAS REPORTED THAT THE LINER TRIAL BROKE DURING THA.

  Patient problems: Insufficient Information

  MAUDE report 21059435 ↗
• MalfunctionMay 20, 2024Break; Break

  IT WAS REPORTED THAT THE TRIAL WAS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19350488 ↗
• MalfunctionMay 3, 2024Break; Break

  IT WAS REPORTED THAT THE INSTRUMENT BROKE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19241963 ↗
• MalfunctionJul 10, 2023Break; Break

  IT WAS REPORTED THAT THE TRIAL LINER BROKE AND REQUIRED REPLACEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17289108 ↗
• MalfunctionDec 6, 2022Break; Entrapment of Device; Break; Entrapment of Device

  IT WAS REPORTED THAT THE PLASTIC BROKE AROUND THE APEX OF THE LINER TRIAL SURROUNDING THE METAL WHILE PLACING IN CUP IMPLANT. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15926140 ↗
• MalfunctionApr 19, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE METAL SCREW TO HOLD TRIAL INTO CUP WAS BROKEN. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14141203 ↗
• MalfunctionJan 13, 2021Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE LOCKING RING AROUND THE SCREW IS GONE AND THE SCREW WILL NOT STAY IN THE TRIAL. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11165091 ↗
• MalfunctionJan 6, 2020Component Missing; Contamination /Decontamination Problem; Missing Information; Component Missing; Contamination /Decontamination Problem; Missing Information

  IT WAS REPORTED THAT THE SPD WAS RE-STERILIZING PAWS WHEN DOWN NOTICED A CRACKED FEMORAL IMPACTOR (2544-01-006) AND POLY THAT WAS MISSING THE RING AROUND THE SCREW (2218-40-456). BOTH ITEMS NEEDS REPLACEMENT.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9552958 ↗
• MalfunctionNov 19, 2019Break; Material Twisted/Bent; Scratched Material; Break; Material Twisted/Bent; Scratched Material

  IT WAS REPORTED THAT THE 40 X 56 + 4 N METAL SCREW PIECE WAS BENT. ALL PIECES RETRIEVED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9341519 ↗
• MalfunctionMay 8, 2018Break; Break

  IT WAS REPORTED THAT THE RETAINING CLIP WOULD NOT HOLD THE LINER SCREW IN PLACE AND KEPT FALLING OFF.

  Patient problems: No Consequences Or Impact To Patient; Not Applicable

  MAUDE report 7493903 ↗
• MalfunctionMar 1, 2018Break; Break

  IT WAS REPORTED THAT THE TWO LINER TRIALS AND ESC REMOVAL TOOLS WERE BROKEN DURING SURGERY. ALL PIECES RETRIEVED FROM THE PATIENT. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7307388 ↗