PINNACLE ALTRX 1221-36-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 10603295016373), received between Jan 10, 2017 and Jun 8, 2026 — classified as 46 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (20 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 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• InjuryJun 8, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CHIEF COMPLAINT WAS HIP PAIN, STEM REVISION WAS PERFORMED AND LINER CHANGED TO PINNACLE DUAL MOBILITY. THERE WAS NO SURGICAL DELAY AND NO HARM TO PATIENT. DOI- (B)(6) 2019. DOR-UNKNOWN. AFFECTED SIDE-LEFT HIP.

  Patient problems: Pain

  MAUDE report 25427019 ↗
• InjuryFeb 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PINN 100 W/GRIPTION 62MM AND ALTRX NEUT 36IDX62OD WERE INVOLVED IN AN EVENT IN FINLAND WHERE REPEATED PATIENT SUBLUXATIONS WERE REPORTED, LEADING TO THE NEED FOR A CUSTOM-MADE DUAL MOBILITY LINER. THE PATIENT EXPERIENCED JOINT INSTABILITY AND SERIOUS INJURY, WITH SUBLUXATIONS AS THE CLINICAL CONSEQUENCE. THE AFFECTED SIDE WAS THE RIGHT. BOTH PRODUCTS ARE ASSOCIATED WITH HIP ACETABULAR PROCEDURES.

  Patient problems: Joint Laxity

  MAUDE report 24267632 ↗
• InjuryNov 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED A PATIENT WAS INFECTED SO IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER WAS PUT IN. ORIGINAL IMPLANT DATE: (B)(6) 2025. EXPLANT DATE: (B)(6) 2025.

  Patient problems: Unspecified Infection

  MAUDE report 23646978 ↗
• InjuryAug 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE ACETABULAR COMPONENT WAS REVISED DUE TO ILIOPSOAS PAIN. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Pain

  MAUDE report 22793306 ↗
• InjuryAug 7, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22738690 ↗
• InjuryJul 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP. SURGEON PERFORMED I&D AND EXCHANGED HEAD AND LINER. THERE WERE NO DELAYS OR COMPLAINTS, AND NO HARM TO THE PATIENT. THERE WERE NO ISSUES WITH THE CUP. IT WAS NOT REVISED. DOI: ON (B)(6) 2021, DOR: ON (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22653516 ↗
• InjuryMay 29, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22107373 ↗
• InjuryMay 20, 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 PAIN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22054724 ↗
• InjuryOct 2, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATED BY PT WHILE BEING TRANSFERRED AND SURGEON ELECTED TO CONVERT TO DM CONSTRUCT. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 20352792 ↗
• InjuryJul 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 19749652 ↗
• InjuryJul 11, 2024Adverse 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: (B)(6) 2023 DOR: (B)(6), 2024 AFFECTED SIDE: UNKNOWN.

  Patient problems: Pain

  MAUDE report 19724118 ↗
• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS BEING REVISED DUE TO SEVERE HO AND BECAUSE THE S ROM STEM HAD MIGRATED INTO VARUS ALIGNMENT. THE SURGEON PERIOD AN ETO TO REMOVE THE S ROM STEM, S ROM SLEEVE AND FEMORAL HEAD. HE PREPPED AND PLACED A COMPETITOR STEM FOR THE FEMUR. HE REMOVED THE 62MM X 36MM NEUTRAL PINNACLE LINER AND REPLACED IT WITH A 62MM X 40MM NEUTRAL PINNACLE LINER. CASE WAS COMPLETED WITHOUT ISSUES. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Extraskeletal ossification

  MAUDE report 19554412 ↗
• InjuryApr 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: A.WERE THERE ANY ADVERSE CONSEQUENCE/S THAT AFFECTED THE PATIENT BECAUSE OF THE REPORTED EVENT? NO B. DID THE EVENT OCCUR DURING THE SURGERY? IF YES, WAS THERE A SURGICAL DELAY? WHAT IS THE DURATION OF THE DELAY? YES, NO DELAY.

  Patient problems: Insufficient Information

  MAUDE report 19127297 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED BECAUSE ABSCESS PRESENT IN JOINT. HEAD AND LINER WERE REMOVED AND REPLACED AFTER IRRIGATION AND DEBRIDEMENT. DOI: (B)(6) 2016. DOR: (B)(6) 2024 AFFECTED SIDE : LEFT SIDE.

  Patient problems: Abscess

  MAUDE report 19089567 ↗
• InjuryMar 26, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: METAL WEAR & REACTION PAIN.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 18980389 ↗
• InjuryDec 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO A DISLOCATED HIP. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18317460 ↗
• InjuryNov 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LINER DISASSOCIATION. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 18184392 ↗
• InjurySep 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD A 36+15.5 METAL ON ALTRX CONSTRUCT. PATIENT CONTINUED TO DISLOCATE AND WAS REVISED TO A PINNACLE REVISION CUP AND PINNACLE DUAL MOBILITY. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17754506 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR DISLOCATION. THE ACETABULAR SHELL, LINER, SCREW AND FEMORAL HEAD WERE EXPLANTED. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 17602952 ↗
• InjuryAug 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE CORAIL STEM SUBSIDED AND PATIENT WAS INFECTED SO ALL PARTS EXPLANTED. THERE WAS A LOOSENING AT THE NON-CEMENTED INTERFACE. THERE WAS NO SURGICAL DELAY. DOI- (B)(6) 2022. DOR- (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17585504 ↗
• InjuryJun 14, 2023Adverse 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) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17128749 ↗
• InjuryApr 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DR. STATED PATIENT WAS INFECTED. REMOVED POLY AND HEAD, TREATING AND REPLACED WITH SAME COMPONENTS. THERE WAS NO SURGICAL DELAY. DOI:(B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16723440 ↗
• InjuryFeb 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO LOOSENING OF THE CUP LINER. ACETABULAR LINER CAME OUT OF THE CUP REVISED LINER AND FEMORAL HEAD. LOOSENING INTERFACE WAS UNKNOWN. CEMENT MANUFACTURER WAS UNKNOWN. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP..

  Patient problems: Inadequate Osseointegration

  MAUDE report 16364465 ↗
• InjuryJun 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION COMPLETED DUE TO RECURRENT DISLOCATION. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 14563661 ↗
• InjuryMar 31, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT POLY LINER WEAR HEAD AND LINER EXCHANGE. DOI: (B)(6) 2012, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 13964358 ↗