PINNACLE 1218-40-764Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295012238), received between Apr 12, 2019 and Jan 2, 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 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.

• InjuryJan 2, 2025Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated; Improper or Incorrect Procedure or Method; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED WITH A DISLOCATED HIP POST HIP REVISION. IN THE PREVIOUS SURGERY, THE SURGEON FELT THAT THE CUP DID NOT HAD THE TIME TO INGROW AND CHOSE NOT TO UTILIZE THE LOCKING RING IN FEAR OF PULLING THE ACETABULAR CUP OUT. A NEW CONSTRAINED LINER AND HEAD BALL WERE PLACED UNEVENTFULLY AND THE LOCKING RING WAS UTILIZED. NO PATIENT HARM NOR DELAY WAS ENCOUNTERED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21061005 ↗
• InjurySep 3, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10489287 ↗
• InjuryJan 28, 2020Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAS A HISTORY OF SURGERIES ON HIS HIP. I DO NOT HAVE PREVIOUS OPERATIVE REPORTS, LABS, OR CLINICAL CORRESPONDENCE TO SHARE. THE HISTORY THAT IS DOCUMENTED WAS STATED TO ME BY THE SURGEON. THIS PATIENT HAD HIS ER HIP REPLACED IN 2009 WITH A SMITH AND NEPHEW BIRMINGHAM METAL ON METAL HIP REPLACEMENT. THIS PATIENT WAS REVISED IN 2012 BY THE SURGEON WHERE THE BIRMINGHAM HIP WAS EXPLANTED AND A SUMMIT STEM WITH A PINNACLE CUP. THE PATIENT BEGAN TO HAVE DISLOCATION ISSUES AFTER THAT REVISION AND SEEN THE SURGEON IN 2013 WHERE HE RECEIVED A 40MM HIP BALL AND CONSTRAINED LINER FOR THE PINNACLE CUP. THIS PATIENT CAME AND SEEN THE SURGEON IN 2018 WITH DISCOMFORT IN HIS HIP. THE SURGEON HAS DONE LABS OVER THE LAST FEW YEARS TO MONITOR HIS CO AND CR LEVELS. OVER TIME THE PATIENTS CO CR LEVELS ELEVATED. THE SURGEON DECIDED TO REVISE THE HIP, HE FOUND THE STEM WAS IMPINGING ON THE 10DEGREE LIP CONSTRAINED LINER AND CREATED METAL DEBRIS IN THE HIP. A NEW HIP BALL AND A NEUTRAL CONSTRAINED LINER WAS IMPLANTED. THE SUMMIT STEM AND PINNACLE CUP WERE LEFT IN SITU. DOI: (B)(6) 2013; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Discomfort; Joint Disorder; No Code Available; Test Result

  MAUDE report 9640227 ↗
• InjuryOct 14, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS TAKEN TO OPERATING ROOM FOR REMOVAL OF HARDWARE DUE TO INFECTION AND ONE STAGE REVISION WAS PERFORMED WITH PLACEMENT OF ANTIBIOTIC BEADS. DOI: (B)(6) 2014; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9186641 ↗
• InjuryApr 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS THE THIRD DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8510692 ↗