PINNACLE Hip Solutions 1218-60-051Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295520313), received between Mar 26, 2021 and Jul 24, 2025 — classified as 14 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6), 2025. DOR: (B)(6), 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22589132 ↗
• InjuryJul 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AND THE ACETABULAR COMPONENTS WERE REMOVED & REPLACED DUE TO CONTINUOUS DISLOCATION OF THE HIP. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22411087 ↗
• InjuryFeb 10, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION AND THE SURGEON DID A SINGLE STAGE REVISION. SURGEON REMOVED ALL IMPLANTS, DID A THOROUGH I&D, AND PUT IN NEW IMPLANTS. THERE WAS NO DELAY IN PROCEDURE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21342936 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 21170348 ↗
• InjuryJan 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A CORAIL SIZE 14 STD OFFSET IMPLANTED AND SIZE 60 CUP. PATIENT HAD UNDERGONE DAIR PROCEDURE FOR INFECTION IN LATE AUGUST, THIS HAD NOT REMOVED THE INFECTION SO IT WAS DECIDED THAT A FULL REVISION PROCEDURE BE CARRIED OUT. ALL IMPLANTS WERE REMOVED AND RECLAIM WITH MULTIHOLE CUP AND DUAL MOBILITY WAS IMPLANTED AS PART OF THE REVISION PROCEDURE.

  Patient problems: Unspecified Infection

  MAUDE report 21073924 ↗
• InjuryMay 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD MDM IMPLANTS IN SITU WITH ACTIVE INFECTION REQUIRING A WASHOUT AND REPLACEMENT OF HEAD AND LINERS. IMPLANTS WERE SENT THE MORNING OF CASE, WHICH STARTED AT 8:00. AT 8:07 THEY COULDN'T BE LOCATED. AT THIS STAGE THE SURGEONS WERE SCRUBBED FOR THE CASE AND THE PATIENT WAS ANAESTHETIZED. THE SURGEONS AGREED TO SLOW DOWN THE SURGERY TO GIVE THE COURIER MORE TIME TO ARRIVE, MEANING THAT THE PATIENT HAD A LONGER ANESTHETIC TIME THAN REQUIRED. WAS PROCEDURE SUCCESSFULLY COMPLETED? --> YES WAS SURGERY DELAYED DUE TO THE REPORTED EVENT? --> YES, IF YES, NUMBER OF MINUTES: --> 30+ MINUTES.

  Patient problems: Unspecified Infection

  MAUDE report 19383588 ↗
• InjuryDec 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE HEAD AND DM POLY LINER THAT WERE REMOVED HAD BEEN PLACED ON NOV 26, 2023 DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM OCCURRED. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18364423 ↗
• InjuryDec 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT INFECTED HIP PROSTHESES WERE REMOVED AND A PROSTALAC WAS PLACED UNEVENTFULLY AFTER A THOROUGH DEBRIDEMENT AND I&D WERE PERFORMED. THE HEAD AND DM POLY LINER THAT WERE REMOVED HAD BEEN PLACED ON (B)(3) 2023 DUE TO DISLOCATION. THERE WAS NO SURGICAL DELAY AND NO PATIENT HARM OCCURRED. DOI: (B)(3) 2023(OTHER IMPLANTS). DOI: (B)(3) 2023(THE HEAD AND DM POLY LINER). DOR: (B)(3) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18358750 ↗
• InjuryNov 8, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT PRESENTED WITH INFECTION SO REMOVED ALL IMPLANTS TO ALLOW FOR INFECTION TO CLEAR. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023. DOR: UNKNOWN. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18093911 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. IT WAS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: JUL 31, 2023. DOR: (B)(6), 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17701896 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO CHRONIC INFECTION. REMOVAL OF ALL IMPLANTS TOOK PLACE. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16777453 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD & LINER EXCHANGE DUE TO INFECTION. NEW HEAD AND LINER IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15233309 ↗
• InjuryDec 2, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO HIP DISLOCATION. DOI : UNKNOWN DOR : (B)(6) 2021 RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12916793 ↗
• InjuryMar 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DUAL MOBILITY COMPONENTS REVISED FOR EARLY INFECTION. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT HIP.

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

  MAUDE report 11575041 ↗