PINNACLE ALTRX 1221-36-462Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 10603295016533), received between Jul 5, 2018 and Dec 18, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryDec 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT HAD A REVISION DUE TO INSTABILITY/DISLOCATION. NO OTHER INFORMATION IS KNOWN. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 23837898 ↗
• InjuryOct 10, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED: A. WAS THERE A SURGICAL DELAY? IF YES, WHAT IS THE DURATION OF THE DELAY? - NO SURGICAL DELAY, B. WHAT IS THE AFFECTED SIDE INVOLVED IN THIS EVENT? - AFFECTED SIDE WAS LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 20422272 ↗
• InjuryMay 13, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED FOR DISLOCATED POSTERIOR. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE : RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 19304413 ↗
• InjuryApr 28, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. IT WAS INDICATED THAT THE PATIENT HAS HAD INFECTION EVENTS AFTER REVISION ( (B)(6) 2016, (B)(6) 2016) WHICH WAS TREATED WITH IV ANTIBIOTICS. NO REVISION SURGERY WAS REPORTED. DOI: (B)(6) 2009 (STEM) DOI: (B)(6) 2016 DOR: NONE REPORTED LEFT HIP.

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

  MAUDE report 11738733 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORD RECEIVED. ON (B)(6) 2019, THE PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY TO ADDRESS PRIMARY OSTEOARTHRITIS, END-STAGE. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2021, THE PATIENT HAD A REVISION RIGHT TOTAL HIP ARTHROPLASTY, TO ADDRESS FAILED RIGHT TOTAL HIP ARTHROPLASTY SECONDARY TO ASEPTIC LOOSE FEMORAL STEM. THE POST-OPERATIVE DIAGNOSIS WAS WELL-FIXED FEMORAL STEM. THE INDICATIONS FOR SURGERY INCLUDED: PAIN, LIMITED ABILITY TO WALK AND EXERCISE. PREOPERATIVE RADIOGRAPHS WERE REPORTED TO SHOW SUBSIDENCE OF THE STEM. DURING THE PROCEDURE, THE SURGEON OBSERVED THAT THE STEM HAS SUBSIDED SLIGHTLY, BUT WAS WELL-FIXED. THE ACETABULAR CUP WAS NOTED TO BE WELL-FIXED AND THERE WAS NO EVIDENCE OF ANY ADVERSE REACTION TO WEAR DEBRIS. THE STEM AND THE ACETABULAR CUP WERE NOT REVISED. THE ACETABULAR LINER AND HEAD WERE REVISED.

  Patient problems: Ambulation or Postural Difficulties; Pain

  MAUDE report 11529490 ↗
• InjuryOct 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER REVISION WAS DUE TO INSTABILITY. DOI: (B)(6) 2020. DOR: (B)(6) 2020. RIGHT HIP.

  Patient problems: No Code Available

  MAUDE report 10750174 ↗
• InjurySep 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT HAD RIGHT SIDE THA REVISED FOR ACETABULAR LINER DISASSOCIATION. CAME THROUGH THE OR FOR PAIN IN OPERATIVE SIDE. NO SPECTACULAR EVENT NOTED/RECORDED PRIOR TO DISASSOCIATION. DOI: (B)(6) 2018. DOR: (B)(6) 2020; AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Pain

  MAUDE report 10567126 ↗
• InjuryAug 29, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS CHRONIC INFECTION. DOI: (B)(6) 2019, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8947084 ↗
• InjuryJul 24, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED THEIR HIP IMMEDIATELY POSTOPERATIVELY. IT HAD ABSOLUTELY NOTHING TO DO WITH ANY OF THE IMPLANTS PUT IN. THE SURGEON ELECTED TO TAKE THEM BACK TO THE OPERATING ROOM TO PUT IN A BIGGER POLY AND HEAD. DOI: UNKNOWN. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8823483 ↗
• InjuryJan 17, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECORD RECEIVED. PINNACLE PPF ALLEGES DISLOCATION AFTER FIRST REVISION. HEAD WAS A NON-DEPUY PRODUCT.

  Patient problems: Joint Dislocation

  MAUDE report 8258449 ↗
• InjuryJan 7, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES INFECTION AFTER FIRST REVISION.

  Patient problems: Arthritis; No Code Available; Pain; Unspecified Infection

  MAUDE report 8223144 ↗
• InjuryDec 13, 2018Biocompatibility; Biocompatibility

  PPF ALLEGES INFECTION REQUIRING ANTIBIOTICS AND ELEVATED METAL IONS. DOI: (B)(6) 2017 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 8159394 ↗
• InjuryNov 27, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED TO ADDRESS INFECTION.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8105675 ↗
• InjuryJul 5, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED TWICE. REMOVED HEAD AND LINER AND REPLACED WITH CONSTRAINED LINER 62+4 AND 40+5 TS HEAD. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7663334 ↗