PINNACLE 1219-28-248Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295013600), received between Apr 20, 2018 and May 19, 2025 — classified as 5 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WILL UNDERGO REVISION SURGERY. A PINNACLE MARATHON 28/48 LIPPED LINER HAS DISASSOCIATED FROM THE CUP. 48MM SECTOR CUP WAS NOT REVISED. STEM WAS COMPETITOR PRODUCT.

  Patient problems: Insufficient Information

  MAUDE report 22047551 ↗
• InjuryNov 16, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  TODAY WAS INFORMED OF A PATIENT WITH A RECURRENTLY DISLOCATING THR. INDEX SURGERY WAS PERFORMED ON (B)(6) 2021 USING A PINNACLE CUP 1217-11-048 AND LINER 1219-28-048; THE STEM AND HEAD WERE PROVIDED BY STRYKER. THE LINER WAS EXCHANGED TO THE LIPPED VARIANT 1219-28-248 ON (B)(6) 2022 DUE TO RECURRENT DISLOCATION. THE CONSTRUCT HAS CONTINUED TO DISLOCATE AND THE PATIENT HAS BEEN REFERRED TO DR IN (B)(6). DR WISHES US TO PROVIDE A CUSTOM MADE DEVICE TO ADDRESS THE PATIENT¿S CHALLENGES.

  Patient problems: Joint Dislocation

  MAUDE report 15804093 ↗
• InjuryMar 28, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  SUBJECT ID: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS DEFINITELY NOT RELATED TO DEVICE AND DEFINITELY RELATED TO PROCEDURE. DOI: (B)(6) 2011. DOE: (B)(6) 2018 (RIGHT HIP). TREATMENT INCLUDES CLOSED REDUCTION / MANIPULATION.

  Patient problems: Joint Dislocation; Pain

  MAUDE report 8460016 ↗
• InjuryJan 18, 2019Naturally Worn; Naturally Worn

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO POLY WEAR.

  Patient problems: No Code Available

  MAUDE report 8260368 ↗
• InjuryApr 20, 2018Fracture; Material Separation; Fracture; Material Separation

  REVISION TOTAL HIP REPLACEMENT, (B)(6) SURGICAL CENTRE (B)(6) 2018. PATIENT PRESENTED AFTER 6 WEEKS OF DISCOMFORT WITH AN AUDIBLE SQUEAK COMING FROM HER HIP REPLACEMENT. UPON DISSECTION DOWN TO THE JOINT REPLACEMENT THE POLYETHYLENE LINER WAS FOUND TO BE FRACTURED INTO MULTIPLE PIECES AND THE CERAMIC HEAD SHOWED SIGNS OF WEAR ON THE LIP OF THE CUP INSITU. THE HEAD AND LINER COMPONENTS WERE REMOVED AND THE INTEGRITY OF THE CUP WAS INSPECTED. THE JOINT REPLACEMENT WAS THEN RE-TRIALLED AND NEW COMPONENTS WERE IMPLANTED LEAVING THE PRIMARY STEM AND PINNACLE CUP INSITU. FEMALE PATIENT DOB: (B)(6).

  Patient problems: Discomfort; Not Applicable; Pain

  MAUDE report 7446305 ↗