PINNACLE 2218-40-158Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295101505), received between Sep 11, 2018 and Nov 15, 2024 — classified as 13 malfunctions.

The most frequently reported specific device problem is “Break” (7 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 18, 2026.

Most reported problems

Recent adverse event reports

The 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 15, 2024Scratched Material; Scratched Material

  IT WAS REPORTED ON (B)(6) 2024 THAT FOLLOWING DECONTAMINATION IT WAS NOTED BY STERILE PROCESSING DEPARTMENT THAT THE LINER TRIAL WAS SCRATCHED AND DAMAGED. THE EVENT DID NOT HAPPEN IN SURGERY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20698273 ↗
• MalfunctionNov 22, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  ADDITIONAL INFORMATION RECEIVED: 1- MISSING PIECE TO HOLD THE TRIAL BOLT IN PLACE. 2- NO DELAY. 3-NO ADVERSE EVENTS. 4-SURGERY DATE NOV 3RD BUT NO USED DURING SURGERY. 5- OFFICE HAS THIS PIECE POSSIBLY THEY CAN PROVIDE .

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

  MAUDE report 18190618 ↗
• MalfunctionOct 11, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT THE CENTER SCREW PIECE OF THE POLY TRIAL DETACHED FROM THE POLY TRIAL. NO LOOSENING AND NO SURGICAL DELAY WAS THERE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17911908 ↗
• MalfunctionDec 12, 2022No Apparent Adverse Event; No Apparent Adverse Event

  THE INSTRUMENTS WAS REPORTED FOR UNKNOWN REASON. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15964581 ↗
• MalfunctionNov 1, 2022Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT WHEN PUTTING TRAYS TOGETHER THEY SAW THE CENTER PIECE MISSING FROM TRIAL. THERE WAS NO SURGICAL DELAY .

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15710765 ↗
• MalfunctionJun 3, 2021Material Twisted/Bent; Material Twisted/Bent

  BROKEN WHITE T-HANDLE, DULL CALCAR PLANAR, STRIPPED LINER TRIAL, CRACKED CUP INSERTER, STRIPPED SCREWDRIVER NO PATIENT CONSEQUENCES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11928812 ↗
• MalfunctionAug 4, 2020Break; Break

  BROKEN LINER TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 10364433 ↗
• MalfunctionMar 10, 2020Break; Detachment of Device or Device Component; Device-Device Incompatibility; Break; Detachment of Device or Device Component; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LOCKING SCREW ON POLY LINER TRIAL BROKEN OFF. CANNOT SCREW TO TRIAL OR IMPLANT CUP FOR TRIALING. 40 X 50MM+4/10 D LINER TRIAL.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9811663 ↗
• MalfunctionFeb 12, 2019Break; Material Disintegration; Component Missing; Scratched Material; Break; Material Disintegration; Component Missing; Scratched Material

  IT WAS REPORTED THAT THE 58 +4/10 POLY TRIAL WAS FOUND IN PIECES ON THE BACK TABLE AFTER TRAILING THE ACETABULAR COMPONENTS AND REAL COMPONENTS IMPLANTED. THE THREE PIECES THAT MAKES THE TRIAL WERE NOT FOUND BUT AFTER SEARCHING, THE SURGEON DECIDED TO REMOVE THE IMPLANTED LINER TO FIND THE MISSING PIECE. IT WAS THEN FOUND IN THE MAIN HOLE AREA OF THE CUP.

  Patient problems: No Code Available

  MAUDE report 8332913 ↗
• MalfunctionOct 22, 2018Break; Break

  IT WAS REPORTED THAT BOLT THAT HOLDS THE LINER INTO THE CUP BROKE OFF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7991271 ↗
• MalfunctionOct 1, 2018Break; Break

  IT WAS REPORTED THAT THE LINERS TRIALS WERE BROKEN.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7924161 ↗
• MalfunctionSep 13, 2018Break; Break

  IT WAS REPORTED THAT THE SCREW ON TOP OF LINER TRIAL WAS IMPACTED OUT OF REST OF LINER TRIAL. THERE WAS NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7872228 ↗
• MalfunctionSep 11, 2018Break; Break

  LINER WAS FOUND BROKEN IN SPD ON WEDNESDAY (B)(6) 2018.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7864266 ↗