PINNACLE ALTRX 1221-36-160Recalls & reported problems

Summary

The FDA's MAUDE database contains 33 adverse event reports that list this exact device (DI 10603295016441), received between Aug 16, 2017 and May 30, 2025 — classified as 33 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (21 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 33 reports, in the reporter's own words as published by the FDA.

• InjuryMay 30, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED FOR A REVISION HIP CASE THAT THE SURGEON WILL USE A CUSTOM PINNACLE DUAL MOBILITY DEVICE FOR REVISION OF AN IN SITU PINNACLE CUP. IMPLANTS IN SITU ARE - 1217-32-060 LOT JM9830, 1221-52-160 LOT JN3989, 1365-52-000 LOT 3669907. THE INDICATION FOR REVISION IS INSTABILITY - RECURRENT DISLOCATION. THE ORIGINAL OPERATION WAS PERFORMED ELSEWHERE, SO WE HAVE LIMITED INFORMATION.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 22117557 ↗
• InjuryDec 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED. STATES, THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 18371975 ↗
• InjuryNov 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18173562 ↗
• InjuryNov 6, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THE PATIENT BENT FORWARD AT THE SINK, DOING SO AGAIN PAIN EVENT LIKE THE FIRST TIME WITH SOUNDS OF THE LEFT HIP. PRESENTATION IN THE EMERGENCY ROOM ON (B)(6) 2023. IN IMAGING DIAGNOSTICS (X-RAY AND COMPUTED TOMOGRAPHY), A LUXATED INLAY WAS FOUND. THIS RESULTED IN AN OPERATION ON (B)(6) 2023 WITH CHANGING THE CUP, INLAY AND HEAD. THE PATIENT FELT A PAINFUL SENSATION IN THE GROIN. FROM THEN ON, HE COULD NO LONGER ADEQUATELY LOAD THE LEFT LEG AND FELT A MECHANICAL BLOCKAGE OF THE HIP JOINT. IN ADDITION, THE PATIENT HEARD A RUBBING SOUND. A SURGICAL DELAY WAS NOT REPORTED.

  Patient problems: Pain

  MAUDE report 18072290 ↗
• InjuryNov 22, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE SURGEON STATED THE PATIENT HAD INDEX HIP REPLACEMENT ROUGHLY 18 YEARS BEFORE. HE ALSO STATED HE HAD A REVISION HIP PROCEDURE DONE AT A (B)(6) CLINIC SOMEWHERE ROUGHLY 5-6 YEARS PRIOR TO THIS SURGERY AND WAS STILL DISLOCATING. DR. (B)(6) ELECTED TO CHANGE THE LINER AND HEAD AND STABILITY WAS EXCELLENT IN HIS OPINION. THE PART NUMBER LISTED IS JUST A GUESS FROM THE DESCRIPTION OF THE LINER WE PULLED OUT. I DON¿T KNOW IF IT WAS ALTR-X OR MARATHON BUT WAS A 36X60 +4/10 DEGREE LINER. THIS IS ALL THE INFORMATION I HAVE. DOI: 5-6 YEARS AGO, DOR: (B)(6) 2021, (UNKNOWN SIDE).

  Patient problems: Joint Dislocation

  MAUDE report 12852207 ↗
• InjuryJun 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ON (B)(6) 2020, THE PATIENT HAD A REVISION TO ADDRESS NONUNION RIGHT INTERTROCHANTERIC FRACTURE HARDWARE FAILURE RIGHT HIP. THE INDICATION FOR SURGERY INCLUDED INCREASING PAIN AND PREOPERATIVE RADIOGRAPHS WHICH SHOW THAT THE FRACTURE HAD SETTLED BUT NOT HEALED AND THE HELICAL BLADE HAD PENETRATED THE FEMORAL HEAD AND IS PROMINENT WITH IN THE PATIENT¿S ACETABULUM. HE PRESENTS NOW FOR HARDWARE REMOVAL AND TOTAL HIP ARTHROPLASTY. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE.

  Patient problems: Joint Dislocation

  MAUDE report 12087996 ↗
• InjuryJun 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS DISLOCATING. SURGEON SWITCHING THE LINER AND THE HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 11969236 ↗
• InjuryMar 19, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD A RT THA PERFORMED ON 1-27. THE PATIENT'S HIP SHOWED SIGNS OF INFECTION AND THAT THE SURGEON WANTED TO DO A HEAD AND LINER EXCHANGE. HE REMOVED THE LINER AND HEAD WITHOUT ANY ISSUES. DOI: (B)(6) 2021 : DOR: (B)(6) 2021 (RIGHT HIP).

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

  MAUDE report 11530126 ↗
• InjuryDec 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO LEG LENGTH AND OFFSET DISCREPANCY. NO SURGICAL DELAY. DOI: (B)(6) 2020; DOR: (B)(6) 2020; UNKNOWN AFFECTED SIDE.

  Patient problems: Physical Asymmetry

  MAUDE report 10984990 ↗
• InjuryDec 2, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE SURGEON PERFORMED THE PATIENT'S ORIGINAL HIP REPLACEMENT ON (B)(6) 2020. THE PATIENT'S HIP BECAME INFECTED AND THE SURGEON WANTED TO PERFORM AN I&D OF THE HIP. WHEN OPENING THE HIP, HE DECIDED TO WASHOUT DEEPER INTO THE PATIENT'S HIP JOINT. HE REMOVED THE FEMORAL HEAD AND POLY LINER, PERFORMED A THOROUGH WASHOUT, AND IMPLANTED A NEW 36X60 +4 10 DEGREE LINER, AND A 36MM +8.5 CERAMIC HEAD. THE HIP WAS REDUCED AND FOUND TO BE SATISFACTORY. THE CLOSING PROCESS BEGAN. DOI: (B)(6) 2020, DOR: (B)(6) 2020, LEFT HIP.

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

  MAUDE report 10935773 ↗
• InjuryJul 5, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR DISLOCATION. THE STEM WAS CHANGED TO A HIGH OFFSET AND THE VERSION OF THE CUP WAS CHANGED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10231249 ↗
• InjuryJun 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS RECURRING DISLOCATION. DOI: (B)(6) 2015, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10184572 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, PHYSICAL LIMITATION, INCONTINENT, PSYCHICAL INSTABILITY AND RASHES AFTER 1ST REVISION. AFTER REVIEW OF MEDICAL RECORDS, NO NEW ALLEGATION WERE REPORTED. DOI: (B)(6) 2012 (HEAD&LINER); DOI: (B)(6) 2009 (CUP, STEM,SCREWS); DOR: NONE REPORTED; LEFT HIP.

  Patient problems: Incontinence; Limited Mobility Of The Implanted Joint; No Code Available; Pain; Rash

  MAUDE report 9885114 ↗
• InjuryJan 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATING THAT THE AFFECTED SIDE IS THE RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9628964 ↗
• InjuryJan 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION (OPEN AND CLOSED REDUCTION), INFECTION REQUIRING IV ANTIBIOTICS AND LOOSENING OF STEM AFTER FIRST REVISION. HEAD AND STEM ARE NON DEPUY PRODUCTS. DOI: (B)(6) 2012; DOR: NONE REPORTED LEFT HIP.

  Patient problems: Joint Dislocation; Unspecified Infection

  MAUDE report 9558415 ↗
• InjuryJan 7, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES DISLOCATION (OPEN AND CLOSED REDUCTION), INFECTION REQUIRING IV ANTIBIOTICS AND LOOSENING OF STEM AFTER FIRST REVISION. HOWEVER, FEMORAL COMPONENTS ARE NON-DEPUY PRODUCTS. DOI: (B)(6) 2012; DOR: NONE REPORTED; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available; Unspecified Infection

  MAUDE report 9557737 ↗
• InjuryJan 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE LINER AND HEAD WERE CHANGED TO CONSTRAINED LINER DUE TO DISLOCATION. DOI: (B)(6) 2019. DOR: (B)(6) 2019, LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9538678 ↗
• InjuryJan 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THERE WAS AN EXCHANGE PARTS DUE TO SHELL POSITION AND RECURRENT DISLOCATION. EXCHANGE TO CONSTRAINED.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9538044 ↗
• InjuryDec 30, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE ALTRX POLY LINER DISASSOCIATED FROM THE PINNACLE CUP. DOI: (B)(6) 2017; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: No Code Available

  MAUDE report 9530916 ↗
• InjuryJun 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATING HIP. IT DISLOCATED 3 TIMES. DOI: UNKNOWN, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8697137 ↗
• InjuryMay 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES INFECTION AFTER FIRST REVISION. DOI: (B)(6) 2013, DOR: (B)(6) 2013, (RIGHT HIP).

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 8632091 ↗
• InjuryApr 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION DUE TO THE CUP BEING MALPOSITIONED. UPDATE PFS REPORTED, FOR BILATERAL HIPS, DECREASED RANGE OF MOTION, INCREASED METAL IONS, TISSUE DEATH/DAMAGE RELATED TO METAL DEBRIS, INFLAMMATORY RESPONSE, AND PATIENT UNABLE TO NORMAL ACTIVITIES LIKE AMBULATION, SITTING LONG PERIODS OF TIME. UPDATE UPON REVIEW PPF ALLEGES DISLOCATION AFTER 1ST REVISION. DOI: (B)(6) 2015; DOR: (B)(6) 2015 (RIGHT HIP).

  Patient problems: Inflammation; Joint Dislocation; Limited Mobility Of The Implanted Joint; No Code Available; Tissue Damage

  MAUDE report 8535326 ↗
• InjuryApr 22, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. LAB VALUES INDICATE ELEVATED METAL ION LEVELS POST REVISION. NO SECOND REVISION HAS BEEN PROVIDED. UPDATE IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PPF ALLEGES PULMONARY EMBOLISM AFTER THE FIRST REVISION. DOI: (B)(6) 2015, DOR: NOT REPORTED (RIGHT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8535250 ↗
• InjuryApr 17, 2019No Apparent Adverse Event; No Apparent Adverse Event

  AFTER THE FIRST REVISION, PPF ALLEGES PULMONARY EMBOLISM. (RIGHT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8524593 ↗
• InjuryApr 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2012; DOR: (B)(6) 2014; (LEFT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8490996 ↗