PINNACLE ALTRX 1221-32-154Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295016182), received between Apr 3, 2018 and Aug 28, 2025 — classified as 9 injuries, 2 malfunctions.

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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionAug 28, 2025Naturally Worn; Naturally Worn

  DURING INSPECTION, THEY NOTICED THAT THE TRIAL LINER WAS BECOMING WORN AND GOUGED. IT WAS THROWN OUT IN ORDER FOR IT NOT TO REINTER CIRCULATION. NO PATIENT INVOLVEMENT

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22914055 ↗
• MalfunctionJun 2, 2025Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event; Manufacturing, Packaging or Shipping Problem; No Apparent Adverse Event

  IT WAS REPORTED THAT AT THE TIME OF ENLISTING THE IMPLANTS, IMPLANT WAS IDENTIFIED WITHOUT THE PACKAGING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22122062 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S POLY + FEMORAL HEAD WAS REVISED DUE TO DISCOMFORT. IT WAS REVISED TO A 36 +4/10 POLY X 54 AND A 36 +12 MM TS CERAMIC FEMORAL HEAD FOR STABILITY. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN; DOR: (B)(6) 2023; AFFECTED SIDE: LEFT HIP.

  Patient problems: Discomfort

  MAUDE report 16252067 ↗
• InjuryJul 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Pain

  MAUDE report 12238473 ↗
• InjuryNov 5, 2020Fracture; Device Dislodged or Dislocated; Migration; Fracture; Device Dislodged or Dislocated; Migration

  HIP REVISION SURGERY FOUND A FINDING IN THE ACETABULUM; PATIENT WHO HAD HAD ONE OF OUR PINNACLE + CORAIL PROSTHESES PLACED TWO YEARS AGO; THE INSERT IS BROKEN AND THE FEMORAL HEAD OF THE PROSTHESIS IS OUT OF THE SOCKET CAUSING METALLOSIS OF THE ENTIRE AREA. PRODUCT: 122132154, LOT: NOT REPORTED. PRODUCT: 136522000, LOT: NOT REPORTED.

  Patient problems: Foreign Body Reaction; Inflammation; Joint Dislocation; No Code Available

  MAUDE report 10792574 ↗
• InjuryJul 21, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT LINER AND HEAD WAS REMOVED DUE TO MULTIPLE DISLOCATIONS. SURGEON IMPLANTED A CONSTRAINED LINER. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10301684 ↗
• InjuryNov 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  I&D OF INFECTED HIP. THESE COMPONENTS PLACED IN ON (B)(6) 2019. IF OTHER, DESCRIBE --> TOTAL HIP, PATIENT STATUS/ OUTCOME / CONSEQUENCES --> YES, PATIENT CONSEQUENCE DESCRIPTION/WAS THERE A CLINICAL OUTCOME EXPERIENCED BY THE PATIENT (INFECTION, INFLAMMATION, ETC.)? --> INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9330202 ↗
• InjuryFeb 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2010 - DOR: (B)(6) 2011, (LEFT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8366097 ↗
• InjuryAug 31, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGES DISLOCATION WITH CLOSED REDUCTION AND DISLOCATION WITH OPEN REDUCTION. DOI: (B)(6) 2011; DOR: (B)(6) 2011; (RIGHT HIP).

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7837254 ↗
• InjuryJul 13, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS CHRONIC DISLOCATION. DOI: (B)(6) 2010; (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7685018 ↗
• InjuryApr 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. DOI: (B)(6) 2018: DOR: (B)(6) 2018: RIGHT HIP.

  Patient problems: Not Applicable; Pain

  MAUDE report 7391640 ↗