PINNACLE 1219-36-458Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295014737), received between Feb 8, 2019 and Oct 10, 2024 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED ON (B)(6) 2024 DUE TO PAINFUL RIGHT THA. SURGEON REVISED HEAD AND LINER AND REMOVED SCREWS.

  Patient problems: Pain

  MAUDE report 20423481 ↗
• InjuryFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE ANY SURGICAL DELAY RELATED TO THE EVENT? NO. B. WHAT IS THE LOOSENING INTERFACE? BONE PROTHESIS. C. WAS THERE ANY INFECTION? EPIDERMIS GERME & PNEUMONIE. D. CLARIFY WHAT IMPLANT(S) WERE REVISED? ALL CUP & STEM. D. PLEASE CONFIRM IF THERE WAS AN INFECTION. THE EVENT DESCRIPTION IS UNCLEAR. SKIN GERMS ONLY.

  Patient problems: Unspecified Infection

  MAUDE report 18789778 ↗
• InjuryDec 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED, DUE TO RIGHT HIP DISLOCATION. NO SURGICAL DELAY. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18378052 ↗
• InjuryMar 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTED TOTAL HIP. I&D WASHOUT WITH HEAD/POLY EXCHANGE. THERE WAS NO SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: (B)(6) 20021, DOR:(B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13801467 ↗
• InjuryAug 10, 2021Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WERE NO INSTRUMENTS BROKEN DURING THE CASE. THE HEAD WAS NOT DISASSOCIATED FROM THE STEM OR LINER WHEN WE WENT TO RETRIEVE THE IMPLANTS. HOWEVER THE X-RAY APPEARED TO SHOW A HEAD DISLOCATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Joint Dislocation

  MAUDE report 12300428 ↗
• InjuryFeb 8, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED ON (B)(6) 2019, TO ADDRESS INFECTION. IT WAS ALSO INDICATED THAT IRRIGATION AND DEBRIDEMENT WITH FEMORAL HEAD/ACETABULAR POLYETHYLENE SWAP WERE DONE. THE INCIDENT INVOLVED THE RIGHT HIP. THE IMPLANT DATE WAS (B)(6) 2018.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8323393 ↗