PINNACLE ALTRX 1221-36-456Recalls & reported problems

Summary

The FDA's MAUDE database contains 140 adverse event reports that list this exact device (DI 10603295016502), received between Jun 22, 2017 and Sep 30, 2026 — classified as 138 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (63 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 140 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Device Dislodged or Dislocated

  It was reported that the patient was revised to constrained liner due to dislocation. DOI: Unknown .DOR: (b)(6) 2026.Affected side: Left hip.

  Patient problems: Joint Dislocation

  MAUDE report 50947513 ↗
• InjuryJul 30, 2026Device Dislodged or Dislocated

  It was reported that patient was dislocating; needed to move to a longer constructDOI: (b)(6 )2026.DOR: (b)(6) 2026.Affected side: Unknown.

  Patient problems: Joint Dislocation

  MAUDE report 50087668 ↗
• InjuryJun 16, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2023. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 25518920 ↗
• InjuryMay 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT WAS REVISED DUE TO PAIN. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Pain

  MAUDE report 25085689 ↗
• InjuryMar 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS A HEAD AND LINER EXCHANGE DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24574565 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. NO ADDITIONAL INFORMATION IS AVAILABLE. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24042815 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THERE WAS INFECTION IN PATIENT'S HIP. IMPLANTS WERE EXTRACTED AND A TEMPORARY SPACER WAS IMPLANTED TO REMOVE INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 24041662 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE POLY LINER AND HEAD BALL WERE EXCHANGED FOR INFECTION. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23680321 ↗
• InjuryOct 30, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT IS APPROXIMATELY 2 WEEKS POSTOPERATIVE AND CULTURED POSITIVE FOR INFECTION. SURGEON DECIDED TO BRING PATIENT TO THE OR FOR I&D WITH POLY EXCHANGE. INTRAOPERATIVELY, THE SURGEON ASCERTAINED THAT THE PURULENT FLUID WAS MOST LIKELY FROM A PRE-EXISTING SARCOMA OF THE POSTERIOR HIP. AFFECTED SIDE: LEFT HIP

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 23424678 ↗
• InjuryAug 26, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT EXPERIENCED CHRONIC DISLOCATION. NO ADDITIONAL INFORMATION WAS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 22898110 ↗
• InjuryJul 23, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED TO DUAL MOBILITY DUE TO DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22579699 ↗
• InjuryJun 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE IMPLANT WAS REVISED FOR DISLOCATION. DURING SURGERY IT WAS DETERMINED THE CUP WAS NOT IN A GOOD POSITION, AND THE STEM WAS SEATED TOO LOW. ALL COMPONENTS WERE REMOVED. A NEW CUP, LINER, STEM, AND HEAD WAS IMPLANTED. AFFECTED AREA: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22329496 ↗
• InjuryJun 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: AFFECTED SIDE WAS RIGHT.

  Patient problems: Unspecified Infection

  MAUDE report 22328695 ↗
• InjuryMay 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. POLY, HEADBALL WAS SWAPPED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22080063 ↗
• InjuryMay 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED HIP IS LEFT SIDE.

  Patient problems: Unspecified Infection

  MAUDE report 21942395 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED FEELING LIKE HIP WOULD DISLOCATE. AFTER REVIEWING X RAYS, IT WAS FOUND THAT STEM UNDERSIZED AND SUBSIDED. SURGEON SCHEDULED A REMOVAL OF STEM TO BE REPLACED WITH A SMITH AND NEPHEW REVISION STEM AND A DEPUY PINNACLE DUAL MOBILITY SYSTEM. SURGERY WAS A SUCCESS. DOI: (B)(6) 2018. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 21871944 ↗
• InjuryJan 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT REVISED FOR DISLOCATION. SURGEON REVISED IMPLANTS TO DM. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21285134 ↗
• InjuryJan 13, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME INFECTED, AND THE SURGEON REMOVED THE HEAD AND LINER AND REPLACED WITH NEW HEAD AND LINER. THERE WAS NO SURGICAL DELAY, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21142594 ↗
• InjuryOct 3, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS DISLOCATING. REVISED CUP TO EMPHASYS DUAL MOBILITY. UNKNOWN SURGICAL DELAY. NO ADDITIONAL INFORMATION IS AVAILABLE. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 20359061 ↗
• InjurySep 24, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD HEAD AND LINER REMOVAL. NO DELAY IN SURGERY. DOI- UNKNOWN. DOR- (B)(6) 2024. AFFECTED SIDE- RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20291435 ↗
• InjurySep 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED: NO DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20266871 ↗
• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION, HEAD LINER EXCHANGE. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20248513 ↗
• InjurySep 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD INFECTED HIP. IMPLANTS WERE REMOVED AND SPACER IMPLANTED. THERE WERE NO ADVERSE EVENTS OR ISSUES WITH EXPLANTED PARTS. NO DELAY IN PROCEDURE. IMPLANTS ARE NOT AVAILABLE FOR RETURN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20181709 ↗
• InjuryJul 12, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. SURGEON CONVERTED IT TO DM. SURGICAL DELAY UNKNOWN. DOI: UNKNOWN. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19733056 ↗
• InjuryMar 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION. DOI: (B)(6) 2014; DOR: (B)(6) 2024; AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 18816583 ↗