PINNACLE ALTRX 1221-32-152Recalls & reported problems

Summary

The FDA's MAUDE database contains 20 adverse event reports that list this exact device (DI 10603295016175), received between Aug 25, 2017 and Dec 8, 2025 — classified as 20 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (9 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 20 most recent of 20 reports, in the reporter's own words as published by the FDA.

• InjuryDec 8, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR NO INFORMATION PROVIDED. DEVICE AND PROCEDURE (RELATEDNESS). DEVICE RELATED: NO INFORMATION PROVIDED. PROCEDURE RELATED: NO INFORMATION PROVIDED. DATE OF EVENT: NO INFORMATION PROVIDED. DATE OF IMPLANT: (B)(6) 2025. DATE OF REVISION: NO INFORMATION PROVIDED. DEVICE LOCATION: NO INFORMATION PROVIDED. TREATMENT/IMPACT: WERE DEPUY SYNTHES COMPONENTS REMOVED: YES. DEPUY SYNTHES PRODUCTS USED: NO INFORMATION PROVIDED. CATALOG NUMBER: NO INFORMATION PROVIDED. LOT NUMBER: NO INFORMATION PROVIDED. COMPONENT TYPE: NO INFORMATION PROVIDED. DESCRIPTION: NO INFORMATION PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 23745915 ↗
• InjuryJun 30, 2025Fracture; Naturally Worn; Fracture; Naturally Worn

  IT WAS REPORTED THAT THE POLY WAS WORN AND BROKEN. DOI: (B)(6) 2009, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 22357882 ↗
• InjurySep 18, 2024Defective Device; Defective Device

  IT WAS REPORTED THAT ONE OF THE COMPONENTS HAD MILLIMETRIC DIFFERENCES IN SIZE WITH WHAT IT WAS REALLY SUPPOSED TO MEASURE. AFTER SURGERY, THE DOCTOR CHECKED THROUGH A SCANNER, AND INDEED THERE WAS A DIFFERENCE IN THE IMPLANTED LINER, ANOTHER SURGERY HAD TO BE DONE TO CHANGE THE COMPONENT.

  Patient problems: Insufficient Information

  MAUDE report 20245617 ↗
• InjuryJun 9, 2023Device Dislodged or Dislocated; Noise, Audible; Device Dislodged or Dislocated; Noise, Audible

  PATIENT INITIATED COMPLAINT: IT WAS REPORTED BY THE PATIENT THAT, "THERE IS A POSSIBLE DEFECT IN HIP REPLACEMENT MATERIAL THAT WAS SENT AND USED BY MY HIP SURGEON DURING (B)(6) 2021. AS A RESULT, I AM NOW HAVING TO BE SCHEDULED FOR A 'REVISION IMPLANT PROCEDURE' SOON. IN THE MEANTIME, PLEASE MAKE NOTE OF THE FOLLOWING IMPLANT MATERIAL THAT WAS INSTALLED INTO MY RIGHT HIP AND JUST MAYBE YOUR COMPANY WILL BE ABLE TO DETERMINE WHAT NEEDS TO BE DONE NEXT BECAUSE I HAVE ALREADY FILED A CONSUMER COMPLAINT WITH THE FDA ON THE FOLLOWING HIP REPLACEMENT MATERIALS: DEPUY SYNTHES PINNACLE SHELL SIZE 52; A+4 19-DEGREE LINER; SUMMIT FEMORAL STEM SIZE 4; STANDARD OFFSET; AND FEMORAL HEAD IS A +1.5 32MM CERAMIC. I LIVE IN (B)(6) AND MY HIP REPLACEMENT SURGERY TOOK PLACE IN (B)(6) 2021 WITHOUT ANY MAJOR COMPLICATIONS AND APPROPRIATE PHYSICAL THERAPY WAS ALSO REQUIRED AND COMPLETED. THE FUNCTION OF MY HIP WITH THE ABOVE MATERIALS FAILED ON (B)(6) 2023. I WAS TAKING A LEISURELY WALK ON A SIDEWALK WHEN THE MATERIALS IN MY HIP MADE A LOUD POPPING SOUND, A BUCKLING DOWN OF MY HIP OCCURRED IMMEDIATELY AND THEN THE MATERIALS/MECHANISM HAS NOT STOPPED MAKING SQUEAKING SOUNDS FROM MY HIP AND FEMUR.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Inflammation; Joint Laxity; Unspecified Musculoskeletal problem

  MAUDE report 17099513 ↗
• InjuryJun 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2022. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (RIGHT HIP). TREATMENT: REVISION; HEAD AND LINER WERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 17079729 ↗
• InjurySep 29, 2022Naturally Worn; Naturally Worn

  CLINICAL ADVERSE EVENT RECEIVED FOR ASEPTIC LOOSENING. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF IMPLANT: (B)(6) 2013; DATE OF REVISION: (B)(6) 2022; DATE OF EVENT: (B)(6) 2022; (RIGHT HIP). TREATMENT: REVISION; LINER, STEM, AND HEAD WERE REMOVED.

  Patient problems: Adhesion(s); Pain; Scar Tissue

  MAUDE report 15502155 ↗
• InjuryJun 20, 2022Naturally Worn; Naturally Worn

  PATIENT WAS REVISED DUE TO POLY WEAR. THERE WAS NO SURGICAL DELAY. THERE WAS NO LOOSENING REPORTED. DOI: (B)(6) 2005; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 14743041 ↗
• InjuryDec 16, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT RECURRING DISLOCATION. LAST REVISION (B)(6) 2021. SURGEON RETAINED STEM AND REMOVED CUP, LINER, AND HEAD. SURGEON PUT NEW DEPUY HEAD ON AND COMPETITIVE CUP. NO IMPLANTS BEING RETURNED. DOI: (B)(6) 2021; DOR: (B)(6) 2021; LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 13018287 ↗
• InjurySep 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  COMPASS CASE (B)(4) REPORTS: THE PATIENT WAS REVISED TO ADDRESS INSTABILITY. THE FEMORAL HEAD, POLYETHYLENE LINER AND CUP WERE REMOVED. ANOTHER VENDORS CUP AND LINER WERE IMPLANTED AND A REVISION 28MM CERAMIC HEAD WAS USED. DOI: UNKNOWN, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 12438315 ↗
• InjuryFeb 3, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONSUMER CLAIM LETTER RECEIVED. THERE IS A PROBLEM WITH METAL ON POLY HIP REPLACEMENT SYSTEM. THE PATIENT EXPERIENCED PAIN, SEVERE ANEMIA DUE TO COBALT METAL POISONING WITH COBALT LEVELS REACHING 9.7 AND CHROMIUM REACHING 1.2 (NO UNITS OF MEASUREMENT PROVIDED. THE PATIENT WAS ORIGINALLY IMPLANTED WITH METAL ON POLY. THE PATIENT WAS REVISED (B)(6) 2020. THE HEAD/LINER WERE REVISED. PATIENT STATED THAT AFTER THE REVISION, THEIR COBALT LEVELS DROPPED AND THEY WERE CURED OF THEIR ANEMIA. DOI: (B)(6) 2016, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Anemia; Pain

  MAUDE report 11272457 ↗
• InjuryDec 29, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS RETURNED TO SURGERY FOR A PAINFUL CYST ON HER RIGHT HIP. THE CYST WAS DEBRIDED AND THE HIP WASHOUT. A NEW HEAD AND LINER WERE PLACED. THERE WAS SOME TRUNNIONOSIS NOTED ON THE HEAD NECK JUNCTION. A NEW LINER AND CERAMIC HEAD WAS PLACED. LABS AND CULTURES ARE STILL PENDING. DOI: (B)(6) 2014, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: Cyst(s); Foreign Body Reaction; Pain

  MAUDE report 11087214 ↗
• InjuryJul 14, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT IS DISLOCATING. CHANGED LINER AND HEAD. DOI: 2014, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 10271057 ↗
• InjuryDec 12, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  REVISION DUE TO DISLOCATION. DATE OF IMPLANTATION: (B)(6) 2018. DATE OF REVISION: (B)(6) 2019 (RIGHT HIP).

  Patient problems: Edema; Joint Dislocation; Joint Disorder; No Code Available; Pain; Synovitis

  MAUDE report 9457871 ↗
• InjurySep 18, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AND PSEUDOTUMOR AFTER FIRST REVISION. DOI: (B)(6) 2017. DOR: NONE. REPORTED LEFT HIP. SEE (B)(4) LEFT HIP 1ST REVISION.

  Patient problems: Hypersensitivity/Allergic reaction; Joint Dislocation

  MAUDE report 9081985 ↗
• InjuryMay 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2011 - DOR: NONE REPORTED, (LEFT HIP). PLEASE SEE (B)(4) FOR THE FIRST SECOND EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 8603463 ↗
• InjuryMar 19, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF ALLEGES PULMONARY EMBOLISM AND INFECTION.

  Patient problems: Pulmonary Embolism; Unspecified Infection

  MAUDE report 8431764 ↗
• InjuryApr 23, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS MULTIPLE DISLOCATIONS. DOI: (B)(6) 2018; DOR: (B)(6) 2018; RIGHT HIP.

  Patient problems: Joint Dislocation; Not Applicable

  MAUDE report 7450289 ↗
• InjuryFeb 23, 2018Disassembly; Fracture; Material Separation; Metal Shedding Debris; Insufficient Device Problem Information; Noise, Audible; Disassembly; Fracture; Material Separation; Metal Shedding Debris; Insufficient Device Problem Information; Noise, Audible

  CLAIM LETTER AND MEDICAL RECORDS RECEIVED. IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, CLAIM LETTER ALLEGES PAIN, POPPING AND SQUEAKING NOISE, FRACTURED LEFT HIP LINER, DISLOCATION, IMPLANT WEAR, SPOTTY BLACK DISCOLORATION ON THE REMOVED IMPLANTS AND SCARRING DUE TO THE REVISION. AFTER THE REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS DISSOCIATION AND ACCELERATED WEAR OF CERAMIC FEMORAL HEAD. REVISION NOTES REPORTED BLACK-TYPE CORROSIVE FLUID, CORRODED HEAD, WEARING ON THE LINER, OXIDATIVE BLACK TISSUE AND CUP DISASSOCIATED AFTER REMOVING THE FEMORAL IMPLANT. X-RAY REPORTED OF ABNORMAL LINER FRACTURED AND ABNORMAL WEAR. CLINICAL VISITS REPORTED OF CLICKING HIP, ECCENTRIC PLACEMENT OF FEMORAL HEAD AND HIP INJURY. SURGICAL PATHOLOGY REPORTED OF SHINY BLACK DISCOLORATION AND FRAGMENT FROM ACETABULAR COMPONENT.

  Patient problems: Host-Tissue Reaction; Injury; Joint Dislocation; Pain; Scarring; Tissue Damage

  MAUDE report 7291711 ↗
• InjuryDec 12, 2017Disassembly; Disassembly

  THE PATIENT WAS REVISED TO ADDRESS LINER DISASSOCIATION. LOCKING MECHANISM OF OLD CUP SHOWS WEAR AND WAS WEAK. CEMENTED IN NEW LINER. DOI: (B)(6) 2017; DOR: (B)(6) 2017: RIGHT HIP.

  Patient problems: Not Applicable

  MAUDE report 7107902 ↗
• InjuryAug 25, 2017Disassembly; Device Dislodged or Dislocated; Disassembly; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION, POSSIBLE POLY DISASSOCIATION.

  Patient problems: Joint Dislocation

  MAUDE report 6821794 ↗