PINNACLE ALTRX 1221-36-460Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI 10603295016526), received between Jun 28, 2017 and Jun 25, 2026 — classified as 36 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (10 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 37 reports, in the reporter's own words as published by the FDA.

• InjuryJun 25, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID WASHOUT AND SWAPPED LINER AND HEAD. THERE WAS NO ADDITIONAL INFORMATION AND NO DELAY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 25622613 ↗
• InjuryApr 24, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. CUP APPEARS TO BE VERTICAL AND OVERLY ANTEVERTED. PATIENT ALSO HAS SPINAL/PELVIC ISSUES. DOI: (B)(6) 2026. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 24984039 ↗
• InjuryMar 16, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, IMPLANTS REMOVED. AFFECTED SIDE-RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24604189 ↗
• InjuryAug 25, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD AND LINER WERE EXCHANGED DUE TO INFECTION. JOINT WAS THOROUGHLY WASHED OUT BEFORE PUTTING IN A NEW LINER AND METAL HEADS. ANTIBIOTIC BEADS WERE USED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22890067 ↗
• 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 TO PROSTALAC DUE TO INFECTION. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22336802 ↗
• InjuryFeb 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION. PATIENT'S PRIMARY FEMORAL HEAD AND LINER WERE REPLACED BY PINNACLE DUAL MOBILITY COMPONENTS TO STABILIZE PATIENT HIP. THERE WAS NO SURGICAL DELAY. DOI: UNKNOWN. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21314967 ↗
• InjurySep 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT UNDERWENT PREVIOUS THA IN (B)(6) 2024 BECAUSE OF A FALL AND ACETABULUM FRACTURE. AFTER THA PATIENT WAS DISLOCATING SO SURGEON DECIDED TO COME BACK TO THE OPERATING ROOM AND REPLACE WITH DUAL MOBILITY. DOI: (B)(6) 2024 DOR: (B)(6), 2024 AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 20182391 ↗
• InjuryOct 24, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS PRESENTED IN OFFICE WITH CONCERNS OF INSTABILITY WITH HIP. SURGERY SCHEDULED TO LENGTHEN NECK AND INVESTIGATE ANY POTENTIAL ISSUES. DOI: (B)(6) 2023. DOE: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 17994867 ↗
• InjuryOct 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ITEMS WERE REMOVED DUE TO A HIP DISLOCATION. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17975304 ↗
• InjurySep 26, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION CONFIRMED THAT THE AFFECTED SITE FOR THIS COMPLAINT WAS THE LEFT SIDE. NO REPORT OF ANY BROKEN INSTRUMENTS. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17818377 ↗
• InjurySep 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE EVENT DID NOT HAPPEN IN SURGERY. IMPLANTS WERE REPORTED FOR UNKNOWN REASON. ADDITIONAL INFORMATION RECEIVED FROM SALES REP STATED: ACTUAL DATE OF REVISION SURGERY WAS (B)(6) 2023. THE PATIENT WAS REVISED TO ADDRESS INFECTION. DEPUY LINER/HEAD/STEM WERE REVISED AND REPLACED WITH DEPUY HEAD/LINER/CEMENT X4 (PROSTALAC). DOI: (B)(6), 2023. DOE: (B)(6), 2023. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17787709 ↗
• InjurySep 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS HAVING ISSUES WITH STABILITY. THE LINER WAS CHANGED AND A LONGER HIP BALL ADDRESSED THE PATIENT'S LEG LENGTH. DOI: (B)(6) 2016. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Physical Asymmetry

  MAUDE report 17699920 ↗
• MalfunctionDec 12, 2022Fracture; Fracture

  PATIENT WAS REVISED DUE TO ARD WAS SHEERED OFF INSERT. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 15960773 ↗
• InjuryJan 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT FELT PAIN AND SOMEWHAT UNSTABLE. SURGERY SCHEDULED AND LEG LENGTH WAS INCREASED. LINER AND HEAD WERE REPLACED WITH 40 MM PLUS 4 NEUTRAL LINER AND 15.5 HEAD. IMPROVED LEG LENGTH AND STABILITY. DOI: (B)(6) 2021. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity; Pain; Physical Asymmetry

  MAUDE report 13335196 ↗
• InjuryJan 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. DOI: (B)(6) 2021; DOR: (B)(6) 2021 ; (RIGHT HIP).

  Patient problems: Unspecified Infection

  MAUDE report 13226646 ↗
• InjuryApr 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED AS "HEAD (COMPETITOR) & LINER EXCHANGE WITH I&D FOR INFECTION. NUMBERS IN FORM BELOW ARE AS REPORTED FROM THE OPERATIVE FIELD." DOI: UNKNOWN. DOR: (B)(6) 2021; AFFECTED SIDE: RIGHT HIP.

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

  MAUDE report 11728717 ↗
• InjuryOct 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT HEAD AND LINER WERE EXCHANGED DUE TO THE PRESENCE OF INFECTION. HEAD, LINER, 2 SCREWS, HOLE ELIMINATOR WERE REMOVED AND REPLACED WITH A NEW LINER AND HEAD. DOI: UNKNOWN, DOR: (B)(6) 2020, AFFECTED SIDE: RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10621555 ↗
• InjurySep 22, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATOR. SURGEON EXPLANTED POLY AND HEAD REVISING WITH CONSTRAINED LINER. DOI: UNKNOWN. DOR: (B)(6) 2020. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10566468 ↗
• InjuryFeb 3, 2020Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED UNSTABLE RECURRENT INSTABILITY OF THE RIGHT HIP. OPERATIVE NOTES INDICATED CLICKING AND MULTIPLE DISLOCATION. DOI: (B)(6) 2011; DOR: (B)(6) 2012; RIGHT HIP 2ND REVISION. PLEASE SEE (B)(4) RIGHT HIP 1ST REVISION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9660846 ↗
• InjuryDec 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS PAINFUL HIP. REPOSITIONED CUP. REMOVED 3 SCREWS AND A HOLE ELIMINATOR BUT NUMBERS COULD NOT BE OBTAINED. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: No Code Available; Pain

  MAUDE report 9397085 ↗
• InjuryNov 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE STICKER SHEETS RECORD RECEIVED. THERE WERE NO ALLEGATION PROVIDED. HOWEVER, ON (B)(4) (RIGHT HIP) PATIENT WAS REVISED DUE TO ELEVATED METAL IONS. LINER WILL NOT BE REPORTED SINCE IT IS POLY. THIS COMPLAINT IS BILATERAL. DOI AND DOR: UNKNOWN; LEFT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Joint Dislocation; Tissue Damage

  MAUDE report 9365366 ↗
• InjuryNov 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON DID A HEAD AND LINER EXCHANGE ON A PATIENT. THE SURGEON DID HIS ORIGINAL SURGERY ON (B)(6) 2019 AT (B)(6). THE PATIENT HAS AN INFECTED HIP. ONLY THE LINER AND HEAD WERE EXCHANGED. TO ANSWER THE QUESTION BELOW- NO INSTRUMENTS WERE BROKEN, THEREFORE NO INSTRUMENTS REMOVED FROM THE PATIENT. DOI: (B)(6) 2019; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9342354 ↗
• InjuryOct 3, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION, STROKE AND HEART ATTACK AFTER FIRST REVISION. DOI: (B)(6) 2007 (STEM); DOI: (B)(6) 2014 (LINER, HEAD, CUP AND SCREWS); DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Cardiac Arrest; Infarction, Cerebral; Unspecified Infection

  MAUDE report 9152360 ↗
• InjuryJan 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTIFICATION RECEIVED FOR REVISION RELATED TO DISLOCATION.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8260959 ↗
• InjuryNov 7, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION REQUIRING IV ANTIBIOTICS BEFORE FIRST REVISION.

  Patient problems: Unspecified Infection

  MAUDE report 8046881 ↗