PINNACLE 1219-28-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295013327), received between Feb 20, 2018 and Jul 16, 2025 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJul 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO HIP DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 22519470 ↗
• InjuryFeb 1, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON SNAPPED OUT FEMORAL HEAD AND LINER. DOI: 2002, DOR: (B)(6) 2021, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 11262768 ↗
• InjuryJul 9, 2020Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATED THAT THE PATIENT RECEIVED A PRIMARY RIGHT THA TO TREAT OSTEOARTHRITIS OF THE HIP. THE SURGEON NOTED THAT THE NATURAL INTERIOR-ANTERIOR ACETABULAR WALL WAS DEFICIENT, REQUIRING CUP PLACEMENT IN 40-45 DEGREES ABDUCTION AND 25-30 DEGREES ANTEVERSION. THE PROCEDURE WAS COMPLETED WITHOUT COMPLICATIONS. THE PATIENT RECEIVED A PINNACLE CUP WITH APEX HOLE ELIMINATOR, MARATHON POLYETHYLENE LINER, ARTICULEZE FEMORAL HEAD, AND SUMMIT STEM.

  Patient problems: No Code Available

  MAUDE report 10252007 ↗
• InjuryMay 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION. DOI: (B)(6) 2003; DOR: NONE REPORTED; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 8588300 ↗
• InjuryApr 8, 2019Fracture; Device Dislodged or Dislocated; Fracture; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS ATTEMPTING TO LUNGE WHEN HE FELT A POP AND PAIN IN HIS HIP. PRESENTED TO ER WITH A DISSOCIATED PINNACLE LINER CONFIRMED INTRA-OP. ONLY 2 ARD TABS WERE PRESENT THE REMAINDER SHEARED OFF. THE SURGEON MADE THE DECISION TO RETAIN THE ACETABULAR SHELL AND REPLACED THE LINER WITH A 36 * 56 NEUTRAL AND THE FEMORAL HEAD WITH A 36+5 CERAMIC +5. DOI: (B)(6) 2013; DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 8490931 ↗
• InjuryFeb 20, 2018Disassembly; Disassembly

  DER STATED THAT THE X-RAY SHOWS POSSIBLE DISASSOCIATION OF LINER. DOI: UNKNOWN; DOR: (B)(6) 2018; LEFT HIP. NO SURGICAL DELAY.

  Patient problems: No Code Available

  MAUDE report 7281927 ↗