PINNACLE ALTRX 1221-36-464Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295016540), received between Feb 12, 2019 and Oct 4, 2024 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryOct 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  WASHOUT FOR INFECTION AND REIMPLANT A TEMPORARY SPACER. LEFT HIP. ORIGINAL DATE OF SURGERY (B)(6) 2024.

  Patient problems: Unspecified Infection

  MAUDE report 20369793 ↗
• InjuryApr 25, 2024Naturally Worn; Naturally Worn

  A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: ACETABULAR CUP LOOSENING WITH PAIN. AT REVISION FRETTING AND CORROSION WAS NOTED ON THE FEMORAL HEAD. THERE WAS MODERATE YELLOWING OF THE ACETABULAR LINER. .

  Patient problems: Pain

  MAUDE report 19181379 ↗
• InjuryJul 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO INFECTION. DATE OF IMPLANT: (B)(6) 2021 DATE OF REVISION: (B)(6) 2022. LEFT HIP. TREATMENT: REMOVAL OF ALL COMPONENTS WERE DEPUY COMPONENTS REMOVED: YES.

  Patient problems: Unspecified Infection

  MAUDE report 15033847 ↗
• InjuryAug 20, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT PRESENTED WITH INFECTION, HEAD AND POLY SWAP OCCURRED FOR A WASH OUT. DOI: UNKNOWN; DOR: (B)(6) 2019, UNKNOWN AFFECTED SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8911674 ↗
• InjuryApr 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8543806 ↗
• InjuryFeb 14, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2017 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8339762 ↗
• InjuryFeb 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2016; DOR: NONE REPORTED; (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 8331071 ↗