PINNACLE ALTRX 1221-40-064Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295393382), received between Sep 5, 2018 and Oct 13, 2023 — classified as 6 injuries.

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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION AND THE SURGEON IMPLANTED DUAL MOBILITY IMPLANTS. THERE WAS NO SURGICAL DELAY. ADDITIONAL EVENT INFORMATION: NO PREVIOUS REVISION DUE TO CHRONIC DISLOCATION, THIS WAS THE FIRST REVISION FOLLOWING THE PRIMARY. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17930432 ↗
• InjuryJun 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT NO PREVIOUS SURGERIES FOR DISLOCATION. THE LINER WAS NEITHER WORN NOR FRACTURED. NO INDICATED DEFICIENCIES WITH OUR PRODUCTS. THIS IS THE FIRST TIME THAT THE SURGEON HAD SEEN THE PATIENT SINCE THE PRIMARY SURGERY.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10178388 ↗
• InjurySep 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2014, NONE REPORTED (LEFT HIP). (B)(4) FOR THE FIRST REVISION.

  Patient problems: Joint Dislocation

  MAUDE report 9046075 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES METAL WEAR AND METALLOSIS.

  Patient problems: Tissue Damage

  MAUDE report 8258378 ↗
• InjuryJan 17, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8257021 ↗
• InjurySep 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO MULTIPLE DISLOCATIONS. DOI: (B)(6) 2018. DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7845428 ↗