PINNACLE ALTRX 1221-40-058Recalls & reported problems

Summary

The FDA's MAUDE database contains 39 adverse event reports that list this exact device (DI 10603295393351), received between Jul 24, 2017 and Sep 1, 2026 — classified as 37 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (8 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 39 reports, in the reporter's own words as published by the FDA.

• InjurySep 1, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient underwent revision surgery for an infected hip. The surgeon changed the cup liner and the femoral head. The acetabular cup was not revised.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Side.

  Patient problems: Unspecified Infection

  MAUDE report 50545865 ↗
• InjuryAug 11, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Unspecified Infection

  MAUDE report 50209213 ↗
• InjuryNov 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6) STUDY NO: OASIS PROD. CLINICAL ADVERSE EVENT RECEIVED FOR REVISION ¿ INFECTION DEVICE AND PROCEDURE (RELATEDNESS), DEVICE RELATED: NO INFORMATION PROVIDED, PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: 17 OCT 2025, DATE OF IMPLANT: (B)(6) 2025, DATE OF REVISION: (B)(6) 2025, DEVICE LOCATION: LEFT. TREATMENT/IMPACT: COMPONENTS REMOVED. (STEM, HEAD, LINER, SHELL) DEPUY SYNTHES PRODUCTS USED: CATALOG NUMBER: 121722058 LOT NUMBER: M9551X COMPONENT TYPE: SHELL DESCRIPTION: PINNACLE SHELL SECTOR 58MM. CATALOG NUMBER: 136540730 LOT NUMBER: 4549269 COMPONENT TYPE: HEAD DESCRIPTION: BIOLOX DELTA REVISION HEAD 12/14 40MM +8.5. CATALOG NUMBER: 101012070 LOT NUMBER: 4724370 COMPONENT TYPE: STEM DESCRIPTION: ACTIS COLLARED HIGH OFFSET FEMORAL STEM SZ 7. CATALOG NUMBER: 122140058 LOT NUMBER: M9976F COMPONENT TYPE: LINER DESCRIPTION: PINNACLE ALTRX 58MM X 40MM NEUTRAL. CATALOG NUMBER: 121730500 LOT NUMBER: PU236738 COMPONENT TYPE: SCREW DESCRIPTION: CANCELLOUS BONE SCREW 30MM.

  Patient problems: Unspecified Infection

  MAUDE report 23533646 ↗
• InjuryOct 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HARDWARE IN THEIR BACK, WAS FEELING LIKE THE HIP WASN'T STABLE. HEAD AND LINER WERE REMOVED AND DUAL MOBILITY WAS IMPLANTED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 23339797 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS INFECTED, ALL IMPLANTS WERE EXTRACTED AND ANTIBIOTIC BEADS WERE IMPLANTED. DOI: (B)(6) 2022. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22686980 ↗
• InjuryJul 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED FOR INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22594952 ↗
• MalfunctionJul 24, 2025Material Deformation; Material Deformation

  IT WAS REPORTED THAT IT WAS FOUND THAT THE RING AROUND THE THREAD IN SCREW WAS BENT AND COULD NOT BE FIXED WHEN I WAS PUTTING THE TRAY BACK TOGETHER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22592456 ↗
• InjuryJun 26, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION IN JOINT,. SURGEON REMOVED HEAD AND LINER TO BE ABLE TO PROPERLY IRRIGATE JOINT AND IMPLANTED NEW HEAD AND LINE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22337832 ↗
• MalfunctionApr 25, 2025Improper or Incorrect Procedure or Method; Material Deformation; Improper or Incorrect Procedure or Method; Material Deformation

  IT WAS REPORTED THAT AN ARD WAS EXTENDED OUTWARD AWAY FROM RIM OF CUPS, AFTER IMPACTION. IT WAS DEEMED, IMPROPERLY SEATED AND REMOVED. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21908227 ↗
• InjuryJan 9, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D LINER AND HEAD WERE CHANGED. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 21112808 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED AND INSERTION OF ANTIBIOTIC SPACER FOR SUSPECTED INFECTION. NO WAY TO CONFIRM INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2024. AFFECTED SIDE : RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18562897 ↗
• InjuryDec 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO AN UNSTABLE HIP. DOI: (B)(6) 2012. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP. ADDITIONAL EVENT INFORMATION STATES: THERE WAS NO SURGICAL DELAY. INSTABILITY WAS NOT DUE TO POLY WEAR. THERE WAS NO EVIDENCE OF MALPOSITIONED COMPONENTS. THERE WERE NO UNDERSIZED COMPONENTS.

  Patient problems: Joint Laxity

  MAUDE report 18320288 ↗
• InjuryJun 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO PERFORM IRRIGATION AND DEBRIDEMENT (I&D) FOR SUSPECTED INFECTION, NO WAY TO CONFIRM. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 17190670 ↗
• InjuryMar 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THIS PATIENT HAD HIS RIGHT HIP REPLACED BY SURGEON WHERE HE HAD A SUMMIT PINNACLE CONSTRUCT IMPLANTED. THIS PATIENT BEGAN TO EXPERIENCE PAIN AND DISCOMFORT IN HIS RIGHT HIP AND FOLLOWED UP WITH SURGEON AND SURGEON SCHEDULED THIS PATIENT FOR AN I&D AS THE WOUND WAS SUSPICIOUS FOR AN INFECTION. DURING THE I&D THE ACETABULAR CUP, HIP BALL, AND LINER WERE EXPLANTED WHILE THE SUMMIT STEM WAS LEFT IN SITU. A THOROUGH IRRIGATION DEBRIDEMENT WAS DONE IN THE WOUND AND A NEW PINNACLE CUP, LINER , AND FEMORAL HEAD WAS IMPLANTED BACK IN. DO NOT HAVE LABS OR CONFIRMATION THAT THE WOUND IS INFECTED WITH A PARTICULAR PATHOGEN. I DO NOT HAVE PATIENT DEMOGRAPHIC¿S TO SHARE FOR REPORT. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Discomfort; Pain; Unspecified Infection

  MAUDE report 16459398 ↗
• InjuryOct 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE LOCAL TISSUE REACTION AROUND PROSTHESIS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2010. DATE OF REVISION: (B)(6) 2022. DATE OF EVENT: (B)(6) 2022. (LEFT HIP).

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 15694799 ↗
• InjuryJul 22, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT HAD CHRONIC DISLOCATIONS. REVISED TO DUAL MOBILITY. NO ADDITIONAL INFORMATION WAS AVAILABLE. DOI: (B)(6) 2020. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 15084327 ↗
• InjuryJun 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONVERSION FROM TOTAL HIP TO PROSTALAC FOR POSSIBLE INFECTION. DOE: (B)(6) 2022.

  Patient problems: Unspecified Infection

  MAUDE report 14851940 ↗
• InjuryJun 7, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTION. THERE WAS NO LOOSENING AND NO SURGICAL DELAY. ORIGINAL DOS WAS (B)(6) 2009 AT (B)(6). DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14622469 ↗
• InjuryJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. THE HEAD AND LINER WERE EXCHANGED. NO SURGICAL DELAY. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14564319 ↗
• InjuryMay 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. THE SURGEON CONDUCTED AND I&D AND REPLACED THE POLY AND HEAD. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14381811 ↗
• InjuryDec 6, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENTS RIGHT HIP WAS REVISED DUE TO THE LINER DISASSOCIATING FROM THE CUP. THE PATIENT PRESENTED IN CLINIC WITH AN AUDIBLE SQUEAKING SOUND FROM HIS HIP. AFTER LOOKING AT THE X-RAY, IT WAS APPARENT THE HEAD WAS ARTICULATING WITH THE INSIDE OF THE SHELL. THE LINER WAS REMOVED AND THE HEAD WAS REMOVED. A HEAD LINER EXCHANGE WAS PERFORMED AND ALL THE OTHER IMPLANTS WERE RETAINED. DOI: (B)(6) 2020, DOR: (B)(6) 2021 , (LEFT HIP).

  Patient problems: Insufficient Information

  MAUDE report 12933710 ↗
• InjuryNov 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. EXCHANGE HIP BALL AND POLY. DOI: UNKNOWN, DOR: (B)(6) 2021 (LEFT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 12819162 ↗
• InjurySep 14, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORT: REVISION WAS DONE DUE TO PERI-PROSTHETIC JOINT INFECTION. NO SURGICAL DELAY. DOI: (B)(6) 2020, DOR: (B)(6) 2021, (LEFT HIP).

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

  MAUDE report 12466687 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2021, AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 11288314 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS I&D WITH HEAD AND LINER CHANGE FOR SUSPECTED ACUTE INFECTION. SALES CONSULTANT HAVE NO ACCESS TO CONFIRM INFECTION. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10810615 ↗