PINNACLE ALTRX 1221-40-158Recalls & reported problems

Summary

The FDA's MAUDE database contains 56 adverse event reports that list this exact device (DI 10603295016571), received between Sep 19, 2017 and Sep 14, 2026 — classified as 56 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (27 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 25 most recent of 56 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Device Dislodged or Dislocated

  It was reported that the patient was dislocating do to poor cup placement incl/Ante per the doctor. Doctor removed the cup and revised to a new cup with DM.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50752106 ↗
• InjuryJun 19, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ENTIRE CONSTRUCT WAS REMOVED AND AN ANTIBIOTIC SPACER WAS PLACED IN ITS POSITION. ALL PIECES WERE REMOVED FROM THE SURGICAL FIELD IMMEDIATELY AND THERE WAS NO HARM DONE TO THE PATIENT. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25562062 ↗
• InjuryJun 4, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT DURING THE PATIENT LAST ADMISSION, PATIENT WAS UNSTABLE IN HEMI HIP WAS CONVERTED TO A TOTAL HIP. PATIENT RETURNS TONIGHT WITH AN INFECTION IN THE HIP. THE HIP WAS WASHED OUT AND A NEW HEAD AND LINER WERE PLACED. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 25394740 ↗
• InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATENT WAS REVISED DUE TO DISLOCATION. CONSTRAINED LINER WAS IMPLANTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22533066 ↗
• InjurySep 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. DOI: UNKNOWN DOR: (B)(6) 2024 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20136118 ↗
• InjuryAug 23, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED, THAT THE PATIENT HAD DISLOCATED, DUE TO CUP IMPLANTED VERTICALLY. S/N CUP WAS IMPLANTED WITH OUR HEAD. NO SURGICAL DELAY. NO OTHER INFORMATION IS AVAILABLE. DOI: UNKNOWN; DOR: (B)(6) 2024; AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 20055310 ↗
• InjuryJul 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19712380 ↗
• InjuryApr 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD MULTIPLE DISLOCATIONS POST TOTAL HIP REPLACEMENT. SHE WAS SCHEDULED FOR CONVERSION FROM A STANDARD BEARING TO A DUAL MOBILITY BEARING TO INCREASE STABILITY. PATIENT MENTIONS TO SURGEON DURING PREOP THAT SHE IS EXPERIENCING SOME GROIN PAIN ALSO. INTRAOPERATIVELY THE HIP IS FOUND TO BE RELATIVELY STABLE. HOWEVER WHEN THE CUP IS CHECKED, THERE APPEARS TO BE SOME MOVEMENT AND IS REMOVED SHOWING FIBROUS INGROWTH ONLY. THE ACETABULUM IS PREPARED AND A NEW CUP IS PLACED ALONG WITH A SCREW FOR ADJUNCT FIXATION. A DUAL MOBILITY BEARING IS PLACED AND A SLIGHTLY LONGER CONSTRUCT IS CHOSEN AS IT CREATED A MORE STABILE CONSTRUCT FOR THE PATIENT. THERE WAS NO DELAY OR HARM TO THE PATIENT. DOI: (B)(6) 2022; DOR: (B)(6) 2024; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 19080183 ↗
• InjuryJan 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT RETURNED TO SURGERY FOR INFECTION. THE HEAD AND LINER WERE SWAPPED OUT DURING THE HIP-DEBRIDEMENT AND IRRIGATION. THERE WERE NO DEFICIENCIES, DELAYS OR BROKEN INSTRUMENTS. DOI: (B)(6) 2023; DOR: (B)(6) 2023; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18449384 ↗
• InjuryDec 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED. AND STATED, THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18274665 ↗
• InjuryAug 29, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR DEEP INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2020. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT HIP). TREATMENT: I&D AND REVISION (HEAD AND LINER WERE REVISED).

  Patient problems: Unspecified Infection

  MAUDE report 17642249 ↗
• InjuryMay 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THERE WAS HEAD & LINER EXCHANGE. THERE WAS NO LOOSENING REPORTED. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16843759 ↗
• InjuryMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTED HIP. THE COMPONENTS WERE REMOVED AND WASHED OUT THE HIP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16512120 ↗
• InjuryMar 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT AS PER SURGEON, PATIENT DISLOCATING. SURGEON REMOVED CUP, HEAD, LINER, SCREW AND RETAINED THE SUMMIT STEM. PART NUMBERS HAD AVAILABLE WERE HARD TO READ. THE SUMMIT STEM : 1570-11-150 L EW9DG1. THE SURGEON PUT IN COMPETITOR CUP AND NEW 12/14 ARTICULATE 28 +5 COCR HEAD. DOI: (B)(6) 2011. DOR: (B)(6) 2023. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16495098 ↗
• InjuryMar 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HIP WAS EXPLANTED FOR INFECTION. TEMPORARY SPACER WAS PUT IN. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 16488090 ↗
• InjuryFeb 27, 2023Adverse 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) 2022, DATE OF REVISION: (B)(6) 2023, (RIGHT HIP). TREATMENT: REVISION; HEAD AND LINER WERE REVISED.

  Patient problems: Unspecified Infection

  MAUDE report 16442823 ↗
• InjuryFeb 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD HIS HIP REPLACED ABOUT 10 YEARS AGO. HE RECENTLY HAD A DISLOCATION. SO THE SURGEON DECIDED TO DO A HIP REVISION AND INSERT A CONSTRAINED LINER. DOI: 10 YEARS AGO. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16385765 ↗
• InjuryFeb 6, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD HEAD AND LINER EXCHANGE DUE TO IRRIGATION AND DEBRIDEMENT. NO SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16304028 ↗
• InjuryJan 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AN I&D WAS PERFORMED ON THIS PATIENT. THE FEMORAL SIDE IS A STRYKER RESTORATION STEM WHICH WAS IMPLANTED BACK ON (B)(6) 2022. PLEASE REFER TO CASE (B)(4) FOR MORE INFORMATION. UNSURE WHAT WAS DONE WITH STEM/HEAD COMPONENT, BUT THE CURRENT LINER 40X58 +4/10DEGREE WAS REMOVED AND A NEW LINER WAS IMPLANTED. DOI- (B)(6) 2022; DOR- (B)(6) 2023; AFFECTED SIDE- LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 16246919 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH ACTIVE INFECTION. HIP WAS INCISED, DEBRIDED, AND LAVAGED FOLLOWED BY NEW POLY AND FEMORAL HEAD. DOI: (B)(6) 2017. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15987208 ↗
• InjuryOct 21, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE CUP HAD SOME MALPOSITION AND THUS THE HEAD ERODED THROUGH A PORTION OF THE POLY. A NEW FACE CHANGING POLY AND HEAD WERE PUT IN. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 15649877 ↗
• InjuryJun 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION HEAD AND LINER REMOVED TO WASH OUT . REPLACED WITH NEW HEAD AND LINER AFTER. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE : LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14742830 ↗
• InjuryFeb 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. I&D WAS COMPLETED. POLY AND HEAD WERE EXCHANGED. DOI: UNKNOWN. DOR: (B)(6) 2022. RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 13592380 ↗
• InjuryDec 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A RIGHT POLY/HEAD SWAP ON PATIENT (DOB (B)(6)) FOR SUSPECTED INFECTION. SURGEON DID THE ORIGINAL SURGERY A COUPLE WEEKS AGO AT (B)(6). DOI: (B)(6) 2021. DOR: (B)(6) 2021. AFFECTED SIDE: RIGHT HIP. ADDITIONAL INFORMATION WAS RECEIVED ON NOVEMBER 27, 2021 AT 1:01 PM STATING. WAS THE INFECTION CONFIRMED? ANSWERS: YES, INFECTION WAS CONFIRMED.

  Patient problems: Unspecified Infection

  MAUDE report 12955030 ↗
• InjurySep 7, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT KEPT DISLOCATING. DOI: UNKNOWN - DOR: (B)(6) 2021 (UNKNOWN SIDE).

  Patient problems: Joint Dislocation

  MAUDE report 12433865 ↗