PINNACLE Hip Solutions 1218-48-041Recalls & reported problems

Summary

The FDA's MAUDE database contains 23 adverse event reports that list this exact device (DI 10603295520177), received between Mar 23, 2021 and Sep 3, 2026 — classified as 22 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 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 23 most recent of 23 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain; Unspecified Infection

  MAUDE report 50595649 ↗
• InjuryJun 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT CONVERSION OF A DUAL MOBILITY TO A PRIMARY LINER AND CERAMIC REVISION HEAD. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Physical Asymmetry

  MAUDE report 25458765 ↗
• InjuryMar 11, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO RECURRENT DISLOCATION. THEY WERE CONVERTED TO A CONSTRAINED LINER. DOI: (B)(6) 2025, DOR: (B)(6) 2026, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 24570397 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. SURGEON WASHED OUT DIS POLY LINER SWAP. THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 23888046 ↗
• InjuryDec 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Joint Dislocation

  MAUDE report 23865796 ↗
• InjuryNov 18, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH INFECTED HIP 2 + YEARS POST THA. ALL WELL FIXED COMPONENTS WERE REMOVED AND A PROSTALAC WAS PLACED WITH NO DELAY NOR PATIENT HARM. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23584335 ↗
• InjuryJul 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. WHILE REMOVING THE LINER AN OSTEOTOME WAS USED AND THE LINER WAS DAMAGED. SINCE THE LINER WAS DAMAGED ALL SMALL FRAGMENTS WERE REMOVED. DOI: ON (B)(6) 2023, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22569262 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 21172395 ↗
• InjuryMay 31, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 19437282 ↗
• InjuryMay 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? THERE WAS NO SURGICAL DELAY. B. WHAT IS THE REASON FOR REVISION? INFECTION. C. WAS THE PATIENT EXPERIENCING ANY ADVERSE SYMPTOMS/CONSEQUENCES THAT LED TO THE REVISION SURGERY? INFECTION. D. WAS THERE AN INFECTION THAT LED TO THE WASHOUT? YES.

  Patient problems: Unspecified Infection

  MAUDE report 19271579 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS AD (B)(6) 2023 PERTAINING TO NON MOM CONSTRUCT WAS REVIEWED BY CLINICIAN. (B)(6) 2023 MRI DEMONSTRATES RIGHT HIP ARTHROPLASTY, MILD INCREASED SIGNAL ON FLUID SENSITIVE SEQUENCES ALONG THE FEMORAL STEM. MODERATE RIGHT GREATER TROCHANTERIC BURSITIS VERSUS HEMATOMA/SEROMA. THE PATIENT ALSO REPORTED HAVING WEAKNESS AND PAIN. THE IMPRESSION IS MILD TROCHANTERIC BURSITIS. ILIOPSOAS TENDINITIS APPEARS TO BE FROM PROMINENCE OF THE IRRITATING PSOAS TENDON ITSELF. CORTICOSTEROID INJECTION IS RECOMMENDED. DOI: (B)(6) 2022 (STEM). DOI: (B)(6) 2023 (LINER, HEAD). DOE: (B)(6) 2023. RIGHT HIP.

  Patient problems: Fatigue; Hematoma; Inflammation; Muscle/Tendon Damage; Pain; Seroma; Swelling/ Edema

  MAUDE report 18442481 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO EARLY STAGE INFECTION. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17755832 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17584792 ↗
• InjuryAug 8, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION WITH DM WENT BACK IN WITH DIFFERENT LINER AND LONGER HEAD BALL. DOI: UNKNOWN, DOR: (B)(6), 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17479221 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE REASON FOR REVISION WAS SURGEON SUSPICION OF INFECTION. IT IS UNKNOWN IN INFECTION WAS PRESENT OR NOT. THE PINNACLE DUAL MOBILITY METAL LINER, POLY LINER AND METAL HEAD WERE REMOVED BEFORE I&D. NEW IMPLANTS OF THE SAME SIZES WERE THEN IMPLANTED. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17200397 ↗
• InjuryJun 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17198991 ↗
• InjuryJun 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 17171126 ↗
• InjuryJun 20, 2023Off-Label Use; Off-Label Use

  PATIENT WAS REVISED DUE TO POSSIBLE INFECTION. LINER AND HEAD WERE EXCHANGED. IT IS UNKNOWN IF THERE WAS ANY SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023.AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17163914 ↗
• InjuryJan 10, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. NO FURTHER INFORMATION IS AVAILABLE. NO SURGICAL DELAY WAS REPORTED. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 16132800 ↗
• InjuryJul 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO DISLOCATION. NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14944607 ↗
• InjuryMar 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT REVISED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13928059 ↗
• MalfunctionMay 12, 2021Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE PDM LINER WOULD NOT STAY SEATED WITH MULTIPLE TRIAL REDUCTIONS, THERE MAY HAVE BEEN TISSUE IN THE VIP TAPER. THE DECISION WAS MADE TO PUT IN ANOTHER PINNACLE POLY LINER. THE BROKEN STEM WAS THE REASON FOR THE SECOND REVISION. THE ONLY IMPLANT THAT WAS NOT EXPLANTED WAS THE 54MM PINNACLE REVISION CUP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11813317 ↗
• InjuryMar 23, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR SAID THE PATIENT DISLOCATED THEIR HIP MULTIPLE TIMES DUE TO INADEQUATE ABDUCTORS. PINNACLE DM LINER WAS REMOVED AND REPLACED WITH A CONSTRAINED LINER. ZIMMER BIOMET STEM WAS RETAINED SO THEIR 28MM HEAD WAS USED. DOI: (B)(6) 2021 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 11554074 ↗