PINNACLE ALTRX 1221-36-258Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 10603295393191), received between Sep 21, 2018 and Oct 27, 2022 — classified as 6 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryOct 27, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED LINER AND HEAD FOR INSTABILITY, RECURRENT DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15681196 ↗
• InjuryAug 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS JUST OVER TWO WEEKS FROM HIS PRIMARY TOTAL HIP REPLACEMENT. HE HAD SOME WOUND DRAINAGE AND WAS BROUGHT TO SURGERY THIS EVENING FOR A HIP I&D WITH A HEAD AND LINER SWAP. THERE WAS NO LOOSENING, NO INSTRUMENT BREAKAGE AND NO DELAY. CULTURE TO DETERMINE AN INFECTION WERE PENDING. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge

  MAUDE report 15216974 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED A HEAD AND LINER EXCHANGE AFTER THE PATIENT HAD PAIN AND TESTS COME BACK SHOWING AN INFECTION IN THE HIP. DOI: (B)(6) 2021, DOR: (B)(6) 2021, RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Pain

  MAUDE report 12526952 ↗
• InjuryJun 1, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED. ORIGINAL DATE OF SURGERY (B)(6) 2017. REVISED ON (B)(6) 2018. DOI: (B)(6) 2018. DOR: (B)(6) 2020; RIGHT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10106202 ↗
• InjuryMay 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE AFFECTED SIDE WAS LEFT.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8654657 ↗
• InjurySep 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE DISLOCATIONS, SURGEON ELECTED TO REVISE THE COMPONENTS BY EXCHANGING THE POLY TO A +4 10 DEGREE AND INCREASING THE HEAD SIZE TO 40MM. DOI: (B)(6) 2018. DOR: (B)(6) 2018. RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7897454 ↗