PINNACLE 1219-28-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295013488), received between Dec 19, 2018 and Jul 23, 2025 — classified as 5 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 18, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD PERIPROSTHETIC FRACTURE OF THE FEMUR, PATIENT COMPLAINED OF LEG LENGTH DISCREPANCY PRIOR TO FRACTURE, POLY LINER AND HEAD WERE CHANGED TO INCREASE LEG LENGTH. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Physical Asymmetry

  MAUDE report 22578130 ↗
• InjuryJun 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME SLIGHTLY UNSTABLE 20 YEARS FOLLOWING THA. SURGEON EXCHANGED PINNACLE LINER AND SROM HEAD. STEM, SLEEVE, AND CUP REMAINED IMPLANTED. NO FURTHER INFORMATION AVAILABLE. NO IMPLANT RECORDS AVAILABLE. DOI: (B)(6) 2001 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 12061935 ↗
• InjuryJan 15, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ACETABULAR REVISION TO INCLUDE REMOVAL OF CUP, LINER AND HEAD DUE TO CRONIC DISLOCATIONS.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9593032 ↗
• InjuryMar 26, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT HIP REVISION. PATIENT COMPLAINED OF PAIN. REMOVED APEX HOLE ELIMINATOR, HEAD AND LINER. NO BROKEN INSTRUMENTS - NO SURGICAL DELAY. ORIGINAL SURGERY (B)(6) 2002.

  Patient problems: No Code Available; Pain

  MAUDE report 8451679 ↗
• InjuryDec 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A LEFT TOTAL HIP REPLACEMENT.. THE SURGEON TOLD ME THAT THE PATIENT HAD BEEN DOING GREAT ALL THESE YEARS UNTIL RECENTLY SHE DISLOCATED. HE SAID THAT SHE DISLOCATED THREE TIMES AND EACH TIME THE ER WAS ABOUT TO REDUCE HER BACK IN. THE SURGEON TOLD ME THAT THE SROM STEM AND PINNACLE CUP LOOKED GREAT ON X-RAY AND ALL HE WANTED TO DO WAS PUT IN A CONSTRAINED LINER TO KEEP HER FROM DISLOCATING.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8181814 ↗