PINNACLE Hip Solutions 1218-58-049Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295520306), received between Oct 1, 2021 and Sep 29, 2026 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjurySep 29, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient required revision of hip implants due to post operative infection. DAIR procedure was carried out.

  Patient problems: Unspecified Infection

  MAUDE report 50931062 ↗
• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that due to infection, surgeon chose to replace head and liner.DOI: Unknown ,DOR: (b)(6) 2026 ,Affected Side: Unknown Hip.

  Patient problems: Unspecified Infection

  MAUDE report 50547091 ↗
• InjuryMay 27, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. HEAD AND LINER WERE SWAPPED. AFFECTED SIDE: LEFT KNEE.

  Patient problems: Unspecified Infection

  MAUDE report 25299714 ↗
• InjuryFeb 23, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD INITIAL SURGERY DONE BY DR. HE WAS UNABLE TO PROVIDE ME WITH THE INITIAL IMPLANT DATE. THE PATIENT SUFFERED A DISLOCATION OF THEIR HIP, REQUIRING A HEAD AND LINER EXCHANGE. A 28+12 SROM HEAD WAS REMOVED AS WELL AS THE 58 PINNACLE DM SHELL. A NEW POLY WAS OPENED AND IMPLANTED. 36MM SROM HEADS WERE TRIALED AND A 36+9 SROM HEAD WAS FOUND TO BE STABLE. THE REAL HEAD WAS OPENED AND IMPLANTED. STABILITY WAS CONFIRMED AND THE CLOSING PROCESS BEGAN. NO DELAYS OR ADVERSE EVENTS TOOK PLACE. DOI- UNKNOWN , DOR- UNKNOWN , AFFECTED SIDE- UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24421622 ↗
• InjuryNov 24, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 23633769 ↗
• InjurySep 19, 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. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23096122 ↗
• InjuryFeb 19, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO ALLEGATION AGAINST THE STEM OR HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 21415177 ↗
• InjuryOct 24, 2024Off-Label Use; Device Dislodged or Dislocated; Off-Label Use; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATED. PATIENT WAS REVISED TO CONSTRAINED LINER FROM DM. LUMBAR FUSION. THERE WAS NO DELAY. ALL PIECES WERE REMOVED. THERE WAS NO IMPLANT FAILURE AND NO LOOSENING. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20524790 ↗
• InjuryJul 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. NO LOOSENING WAS THERE. DOI: (B)(6) 2022. DOR:(B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 19761221 ↗
• InjuryNov 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SWAPPED OUT IMPLANTS DUE TO AN INFECTION. A SAME SIZE IMPLANT WAS PUT BACK AFTER TAKING OUT. UNKNOWN SURGICAL DELAY. DOI: (B)(6), 2023. DOR: (B)(6), 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 18063883 ↗
• InjurySep 25, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO DISLOCATION. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. (LEFT HIP). TREATMENT: HEAD AND LINER WERE REVISED. REVISION DUE TO DISLOCATION. THE TWO ARTICULATING SURFACES ARE THE PINNACLE DM LINER AND BIMENTUM LINER, WHICH HAVE BEEN REPORTED FOR THE DISLOCATION. IT IS REASONABLE TO CONCLUDE THE REVISED FEMORAL HEAD DID NOT CAUSE OR CONTRIBUTE TO THE DISLOCATION AS IT IS ENCLOSED WITHIN THE BIMENTUM LINER AND DOES NOT INTERACT WITH THE ARTICULATING SURFACES.

  Patient problems: Joint Dislocation

  MAUDE report 17807961 ↗
• InjuryMay 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD A HIP DISLOCATION. THE STEM, DUAL MOBILITY LINER & HEAD WERE REVISED. RECLAIM & PINNACLE CONSTRAINED LINER WERE IMPLANTED. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16875919 ↗
• InjuryJan 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HIP JOINT INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 16226137 ↗
• InjuryDec 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION AFTER HIP REPLACEMENT. PATIENT BROUGHT TO OR FOR HIP REVISION. UPON EXPOSURE, SURGEON NOTED CUP HAD MOVED INTO A NEUTRAL OR EVEN RETROVERTED POSITION. CUP WAS REMOVED AND NEW CUP PLACED WITH INCREASED ANTEVERSION TO ACHIEVE HIP STABILITY AND SCREWS WERE PLACED TO ENSURE MAINTAINED POSITION. NO PATIENT HARM OCCURRED. AS IMPLANTS WERE RECENTLY PLACED THE CUP HAD YET TO INGROW. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15939872 ↗
• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED SECONDARY TO PAIN. DOI: UNKNOWN; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain

  MAUDE report 14279241 ↗
• InjuryMar 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13721067 ↗
• InjuryFeb 11, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO DISLOCATION. SURGEON REMOVED DUAL MOBILITY IMPLANT AND IMPLANTED CONSTRAINED LINER. DOI: UNK. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13513864 ↗
• InjuryNov 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION WASHOUT. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12882825 ↗
• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THERE WAS NO SURGICAL DELAY, NO ALLEGED DEFICIENCY. REASON FOR REVISION WAS INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 12813178 ↗
• InjuryOct 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2021, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 12562499 ↗