PINNACLE ALTRX 1221-32-254Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 10603295016205), received between May 29, 2018 and Nov 11, 2025 — classified as 10 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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.

• InjuryNov 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT 1ST REVISION FOR DISLOCATION. ONLY HEAD AND LINER WERE REVISED. THIS REPORT IS RELATED TO (B)(4) WHICH CAPTURES SECOND REVISION SURGERY.

  Patient problems: Joint Dislocation

  MAUDE report 23526437 ↗
• InjuryAug 20, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT RETURNED TO SURGERY AFTER SEVERAL DISLOCATIONS. THE CUP WAS REVISED TOO. AFFECTED SIDE: LEFT SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 22849319 ↗
• InjuryJan 28, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAS DISLOCATION AND PINNACLE DUAL MOBILITY IS PLANNED.

  Patient problems: Joint Dislocation

  MAUDE report 21253593 ↗
• InjuryJan 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO SOME INSTABILITY. DOI: (B)(6) 2005. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 13205230 ↗
• InjurySep 27, 2021Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE HIP WAS NOT REDUCED AS HEAD SIZE WAS MISMATCHED (TOO LARGE) FOR THE LINER.

  Patient problems: Insufficient Information

  MAUDE report 12533662 ↗
• InjuryJul 13, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO TOTAL HIP DISLOCATED, SO THE DOCTOR WANTED TO DO A HEAD AND LINER EXCHANGE. HE DECIDED TO PUT IN A +5 HEAD INSTEAD OF THE +1 THAT THE PATIENT ORIGINALLY HAD IN. DOCTOR CHECKED ROTATION AND THE PATIENTS HIP FELT STABLE. I WILL NOT BE RETURNING ANY IMPLANTS. DOI: (B)(6) 2020, DOR: (B)(6) 2021. (LEFT HIP).

  Patient problems: Joint Dislocation

  MAUDE report 12159416 ↗
• InjuryNov 20, 2020Naturally Worn; Naturally Worn

  IT WAS STATED THAT PATIENT HAD SIGNS OF INSTABILITY, PSEUDO TUMORS, TRUNIONOSIS AND OSTEOLYSIS. UPON REMOVAL OF THE ARTICULEZE HEAD THERE WAS VERY INSIGNIFICANT SIGNS OF TRUNIONOSIS. UPON REMOVAL OF THE ALTRIX LINER, IT REVEALED IT WAS THE LINER THAT HAD WORN AND WAS PROBABLY RESPONSIBLE FOR THE MASSIVE OSTEOLYSIS ON FEMUR AND CUP. DOI: (B)(6) 2009, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Osteolysis

  MAUDE report 10874954 ↗
• InjuryNov 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO A 54 X 32 NEUTRAL + 4 CONSTRAINED POLY DUE TO DISLOCATION AND SOME DEGREE OF DEMENTIA. DOI: UNKNOWN. DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10835999 ↗
• MalfunctionJun 11, 2020Difficult to Insert; Difficult to Insert

  IT WAS REPORTED THAT THE SURGEON HAD REAMED THE PATIENTS' ACETABULUM TO 53MM AND INSERTED A 54MM POROCOAT SECTOR CUP. HE DRILLED AND INSERTED A SCREW INTO THE CUP AND DECIDED ON A 54X32MM LIPPED LINER. WHEN ATTEMPTING TO IMPACT THE LINER INTO PLACE, THE LINER NEVER ENGAGED INTO THE CUP. THE SURGEON PROCEEDED TO DOUBLE-CHECK HIS SCREW PLACEMENT AND CUP PLACEMENT, AS WELL AS ANY SURROUNDING SOFT TISSUES. EVERYTHING WAS FOUND TO BE WELL-POSITIONED, YET THE LINER STILL WOULD NOT ENGAGE. A NEW LINER WAS OPENED AND IMPLANTED WITHOUT A PROBLEM. UNFORTUNATELY, THE LINER WAS DISCARDED BY STAFF IN THE OPERATING ROOM, SO I WAS UNABLE TO RETRIEVE IT IN ORDER TO SEND IT IN FOR EXAMINATION. DOI: UNKNOWN, DOR: (B)(6) 2020 LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 10144839 ↗
• InjuryJan 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES FRACTURE (BONE) AND INFECTION AFTER FIRST REVISION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8276903 ↗
• InjuryMay 29, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND PUT IN A CONSTRAINED LINER. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7549865 ↗