PINNACLE 1218-28-050Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 10603295011118), received between May 4, 2018 and Feb 26, 2021 — classified as 2 injuries.

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

• InjuryFeb 26, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS REVIEWED: PATIENT RECEIVED PRIMARY RIGHT TOTAL HIP ENDOPROSTHESIS ON (B)(6) 2007 TO ADDRESS ACUTE FEMORAL HEAD NECROSIS. ON (B)(6) 2020, PATIENT EXPERIENCED A RIGHT HIP SNAPPING SOUND WHEN GETTING UP FROM A SQUATTING/STOOPING POSITION, RESULTING IN ACUTE, SEVERE PAIN IN THE RIGHT HIP. WHEN WALKING, A NOTICEABLE SQUEAKING AND CREAKING SOUND WAS AUDIBLE FROM HER HIP. THERE WAS NO RELATED TRAUMA OR FALL EVENT ASSOCIATED WITH THIS ONSET. RADIOLOGICAL DIAGNOSIS SHOWED UNCENTERING OF THE FEMORAL HEAD, INDICATIVE OF INLAY DISLOCATION WITH METAL-TO-CERAMIC CONTACT OF THE ARTIFICIAL HIP JOINT. "ADVANCED WEAR IS FOUND WITH DECENTERING OF THE HEAD AND LIKELY COMPLETE WEAR OF THE PLASTIC INLAY. NO CLASSIC SIGNS OF LOOSENING AT THE CUP OR SHAFT WERE FOUND". THIS REQUIRED IMMEDIATE RE-OPERATION WITH INLAY/ACETABULAR REPLACEMENT. IT IS NOTED THAT THIS IS A SINGLE EXAMINATION. A SERIES OF COMPARATIVE X-RAYS OVER TIME IS REQUIRED TO DEFINITIVELY DIAGNOSE POLYETHYLENE BEARING WEAR BY RADIOGRAPHS ALONE. THE REVISION PROCEDURE WAS CONDUCTED ON 07/31/2020. REVISING SURGEON NOTED THAT THE CERAMIC FEMORAL HEAD HAD MADE CONTACT WITH THE UNCOVERED METAL ACETABULAR CUP. THE RADIOLOGIST HAD S

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

  MAUDE report 11387826 ↗
• InjuryMay 4, 2018Naturally Worn; Naturally Worn

  DER STATES THAT SUPERIOR POLY WEAR. NO FALLS, TRAUMA, OR COMORBIDITIES. DOI: (B)(6) 2013; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Not Applicable

  MAUDE report 7486307 ↗