PINNACLE ALTRX 1221-32-056Recalls & reported problems

Summary

The FDA's MAUDE database contains 18 adverse event reports that list this exact device (DI 10603295016137), received between Dec 7, 2017 and Jun 27, 2024 — classified as 1 death, 17 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 18 most recent of 18 reports, in the reporter's own words as published by the FDA.

• InjuryJun 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A REVISED ACETABULAR LINER AND FEMORAL HEAD DUE TO LINER DISASSOCIATION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2016, DOR: (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19623708 ↗
• InjuryOct 14, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI: (B)(6) 2022, DOR: (B)(6) 2022, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15605053 ↗
• InjuryAug 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON TOOK ALL IMPLANTS OUT DUE TO INFECTION. THERE WAS A REPORTED NON-CEMENTED LOOSENING OF FEMUR AND CUP. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15232899 ↗
• InjuryApr 1, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13977074 ↗
• InjuryMar 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT 4 WEEKS POST SURGERY, THE PATIENT CAME BACK WITH HIP PROBLEMS AND NOISE FROM THE HIP. THE CAUSE WAS POLY LINER DISSOCIATION LEADING TO REVISION SURGERY AND EXCHANGE OF THE POLY LINER. THE PINNACLE CUP WAS LEFT WELL FIXED, ONLY LINER EXCHANGE WAS PERFORMED. NO SURGICAL DELAY.

  Patient problems: Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 11590524 ↗
• InjuryFeb 4, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  WHEN STOOPING AT HOME, PATIENT EXPERIENCED SHOOTING PAIN IN RIGHT HIP. INLAY DISLOCATION SEEN IN X-RAY. REVISION WITH INLAY CHANGE ON JANUARY 19TH.

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

  MAUDE report 11280377 ↗
• InjuryJan 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS " PATIENT UNSTABLE". DOI: (B)(6) 2017 - DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Joint Laxity

  MAUDE report 11164915 ↗
• InjuryFeb 25, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT DEVELOPED OSTEOLYSIS AROUND THE FEMORAL COMPONENT CAUSING LOOSENING. THE CORAIL SIZE 10 KLA WAS REMOVED ALONG WITH THE 32+1 COBALT CHROME HEAD AND 32 X 56 NEUTRAL LINER. AN AML STEM WAS PLACED WITH NEW LINER AND HEAD BALL. THE LOT NUMBERS FROM SHEET FROM PREVIOUS CASE WERE NOT ABLE TO READ DUE TO BLURRINESS. DOI: (B)(6) 2020. DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Osteolysis

  MAUDE report 9750359 ↗
• InjuryJan 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9608262 ↗
• InjurySep 17, 2019Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD POLY WEAR. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 9078046 ↗
• InjuryOct 30, 2018Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available; Device Dislodged or Dislocated; Appropriate Device Problem Term/Code Not Available

  PPF AND STICKERS SHEETS RECEIVED. PPF ALLEGES ABDUCTOR MUSCLE REPAIR, DISLOCATION, AND INFECTION.

  Patient problems: Joint Dislocation; Tissue Damage; Unspecified Infection

  MAUDE report 8020894 ↗
• InjuryAug 21, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE POLY LINER BECAME DISLODGED FROM CUP. PATIENT STATED THAT HE WAS DANCING AND FELT A ¿POP¿ IN HIS HIP AND KNEW SOMETHING WAS NOT RIGHT. PATIENT WENT TO THE EMERGENCY ROOM, AFTER X-RAYS AND CT SCAN IT WAS VERIFIED THAT THE LINER HAD DISLODGED FROM THE CUP. THE SURGEON DID NOT KNOW IF THE LINER WAS DEFECTIVE OR IF THERE WAS IMPINGEMENT THAT COULD HAVE CAUSED THE SEPARATION OF THE LINER. SURGEON REVISED THE ACETABULAR CUP BECAUSE HE FELT THE POSITION OF THE CUP WAS NOT OPTIMAL. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7800647 ↗
• InjuryJul 27, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2012; (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7726196 ↗
• InjuryMay 22, 2018Disassembly; Disassembly

  THE PATIENT WAS REVISED TO ADDRESS DISASSOCIATION. DOI: (B)(6) 2017; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: No Code Available; Not Applicable

  MAUDE report 7532728 ↗
• InjuryMay 14, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: 2013; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7510342 ↗
• InjuryJan 9, 2018Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated

  DER STATES THAT THE ACETABULAR LINER HAD COMPLETELY DISASSOCIATED FROM THE SHELL. PUT IN NEW LINER AND HEAD. DOI: (B)(6) 2016; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7174684 ↗
• InjuryJan 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. DOI: (B)(6) 2014; DOR: (B)(6) 2017; RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7167378 ↗
• DeathDec 7, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  CLINICAL DER STATED THAT THE PATIENT EXPERIENCED AN ADVERSE EVENT OF INFECTION OF OPERATIVE HIP. IT WAS ALSO INDICATED THAT THE EVENT DOES MEET THE DEFINITION OF SERIOUS AND IS CONSIDERED SEVERE. THE EVENT IS DEFINITELY NOT RELATED TO DEVICE AND HAS A REMOTE POSSIBILITY OF BEING RELATED TO PROCEDURE. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED ON (B)(6) 2017. THIS EVENT LED TO THE PATIENT'S DEATH ON (B)(6) 2017. DOI: (B)(6) 2017; DOE: (B)(6) 2017; RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 7098842 ↗