PINNACLE 1217-06-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295008774), received between Jan 7, 2019 and Feb 18, 2020 — classified as 2 injuries.

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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UNF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, FAILED (METAL-ON-METAL) RIGHT TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES REPORTED THAT THERE WAS SOME GRAY DISCOLORATION OVER THE GREATER TROCHANTER END THE BURSA, ANTERIOR PORTION CLOSER TO THE HIP JOINT, WHICH APPEARED DARK WITH DISCOLORATION RELATED TO METAL DEBRIS GENERATION. THERE WAS SOME HETEROTOPIC BONE ANTERIORLY AND SUPERIORLY AROUND THE ACETABULAR SHELL, AND A SMALL AMOUNT OF ECTOPIC BONE ALONG THE POSTERIOR RIM COVERING THE LINER LOCKING MECHANISM, 2 OF THEM WERE REMOVED WITH SCREWDRIVERS, BUT THE THIRD SCREW WAS FOUND TO BE STRIPPED AND COULD NOT BE REMOVED, THIS WAS THEN REMOVED WITH A SCREW REMOVAL TECHNIQUE. DOI: (B)(6) 2007; DOR: (B)(6) 2017; RIGHT HIP. (B)(4) CAPTURES 1ST REVISION.

  Patient problems: No Code Available

  MAUDE report 9718925 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION, METAL WEAR AND METALLOSIS. DOI: (B)(6) 2006; DOR: (B)(6) 2015; (RIGHT HIP).

  Patient problems: Discomfort; Inflammation; Pain; Tissue Damage; Unspecified Infection

  MAUDE report 8221625 ↗