PINNACLE ALTRX 1221-40-062Recalls & reported problems

Summary

The FDA's MAUDE database contains 13 adverse event reports that list this exact device (DI 10603295393375), received between Jul 20, 2018 and Sep 28, 2026 — classified as 13 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 13 most recent of 13 reports, in the reporter's own words as published by the FDA.

• InjurySep 28, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50919842 ↗
• InjuryDec 31, 2025Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  (B)(6) SCHOOL OF ENGINEERING AT (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: "REVISION FOR INFECTION. THE ARTICULAR SURFACE OF THE FEMORAL HEAD SHOWS SEVERE METAL TRANSFER. THE NON-ARTICULAR SURFACE OF THE POLY LINER SHOWS MINOR YELLOWING. THE ARTICULAR SURFACE SHOWS MODERATE YELLOWING AND EMBEDDED METAL"

  Patient problems: Unspecified Infection

  MAUDE report 23934541 ↗
• InjurySep 4, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTED RIGHT TOTAL HIP. THE SURGEON DID A WASHOUT WITH HEAD AND LINER EXCHANGE. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22962086 ↗
• InjuryMay 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21983959 ↗
• InjuryMay 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS REASON FOR REVISION: REVISION DUE TO INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 21981283 ↗
• InjuryMar 13, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN INFECTION. THE LINER AND HEAD WERE REMOVED AND REPLACED WITH THE SAME SIZES. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18895907 ↗
• InjurySep 25, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO TOTAL HIP INFECTION. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17807301 ↗
• InjuryNov 17, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS PATIENT HAS A RIGHT TOTAL HIP THAT IS DISLOCATING. THE SURGEON DID A LINER AND HEAD EXCHANGE TO STABILIZE IT. DOI: (B)(6) 2021. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12829150 ↗
• InjuryOct 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE COMPONENTS WERE REMOVED DUE TO INFECTION AND REPLACED WITH ANTIBIOTIC SPACER. DOI: (B)(6) 2021, DOR: (B)(6) 2021, UNK HIP.

  Patient problems: Unspecified Infection

  MAUDE report 12656715 ↗
• InjuryApr 13, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WENT IN FOR I&D AND POLY EXCHANGE FOR INFECTION. STEM BECAME LOOSE WHEN REMOVING HEAD. DOCTOR BROACHED AND PUT IN BIGGER STEM. DOI: (B)(6) 2021; DOR: (B)(6) 2021; AFFECTED SIDE: UNKNOWN HIP.

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

  MAUDE report 11655276 ↗
• InjuryDec 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, LIMITATION, NUMBNESS AND DISCOMFORT AFTER 1ST REVISION. STEM HAS BEEN REPORTED ON (B)(4). DOI: (B)(6) 2008 (CUP). DOI: (B)(6) 2017; DOR: NONE REPORTED; RIGHT HIP.

  Patient problems: Discomfort; Hypoesthesia; Pain

  MAUDE report 9497046 ↗
• InjuryOct 15, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON SAID THE PATIENT WAS FINE FOR 1 YEAR. THEN HAD INCREASED PAIN. HE CHANGED THE HEAD AND LINER AND DID SOME DEBRIDEMENTS AND NOW THE PATIENT IS SAID TO BE FEELING BETTER. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 9194423 ↗
• InjuryJul 20, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT ON (B)(6) OF 2018 THE PATIENT HAD HIS FIRST LEFT HIP REVISION DONE WHERE THE SURGEON REMOVED A METAL ON METAL PINNACLE LINER AND HEAD. THE SURGEON LET ME KNOW THE PATIENT HAD DISLOCATED TWICE SINCE THAT JANUARY SURGERY AND WAS NEEDING ANOTHER REVISION WITH THE CONSTRAINED LINER. THE SURGEON REMOVED THE HEAD AND THE POLY LINER. DOI: (B)(6) 2018; DOR: (B)(6) 2018; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 7706054 ↗