PINNACLE 1219-28-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295013471), received between Feb 5, 2019 and Apr 8, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Fitting Problem” (1 report).

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.

• InjuryApr 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 19067145 ↗
• MalfunctionFeb 5, 2019Fitting Problem; Fitting Problem

  THERE WAS AN INTERCURRENCE WITH OUR MATERIAL THE INSERT 52 FOR HEAD 28 DID NOT FIT CORRECTLY. SEVERAL ATTEMPTS WERE MADE TO FIT THE INSERT, AND AFTER MANY ATTEMPTS THE SURGEON DECIDED TO CHANGE THE ACETABULAR DOME AND INSERT, BUT TO MAKE THIS CHANGE IT WAS NECESSARY TO OPEN ANOTHER ACETABULAR DOME, HEAD, AN INSERT AND TWO OTHER SCREWS, BECAUSE IN THE NEW POSITION OF THE ACETABULAR DOME THE MATERIALS THAT WERE ALREADY OPEN DID NOT MEET THE NEED FOR FIXING. AFTER REMOVAL OF THE DEFECTIVE MATERIAL FROM THE SURGICAL CENTER, IT WAS POSSIBLE TO PERFORM SOME TESTS AND FOUND THAT IT WAS ACTUALLY LARGER, EVEN THOUGH THE IMPLANTS HAD THE LASER MARKING OF THE FACTORY. ALREADY WITH THE NEW IMPLANTS OPENED IT WAS ONLY NECESSARY TO FIT THE INSERT WITH THE FINGERS AND TO IMPACT TO LOCK THE COMPONENT IN ITS PROPER PLACE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8304292 ↗