PINNACLE 2218-40-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295430032), received between May 13, 2019 and Nov 30, 2021 — classified as 3 malfunctions.

The most frequently reported specific device problem is “Device-Device Incompatibility” (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 18, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• MalfunctionNov 30, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE SURGEON COMPLAINED THAT THE LINER TRIALS FOR THE SIZE 40 WERE NOT SEATING PROPERLY. SURGEON REQUESTS NEW SET.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12897091 ↗
• MalfunctionNov 29, 2021Device-Device Incompatibility; Device-Device Incompatibility

  IT WAS REPORTED THAT THE LINER TRIAL WOULDN'T SEAT IN THE CUP AND THE SURGEON ASKED TO GET A SET IN THAT WOULD WORK. NO SURGICAL DELAY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12883239 ↗
• MalfunctionMay 13, 2019Break; Break

  IT WAS REPORTED THAT DURING RECLAIM HIP REVISION, SEVERAL INSTRUMENTS HEIGHT SEGMENTS WERE DAMAGED AND NECK TRIAL SCREWS STRIPPED. A SCREW IN THE DOME OF A 40MM LINER ALSO DISLODGED. NO SURGICAL DELAY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8605560 ↗