PINNACLE ALTRX 1221-40-460Recalls & reported problems

Summary

The FDA's MAUDE database contains 40 adverse event reports that list this exact device (DI 10603295016618), received between Sep 1, 2017 and Sep 3, 2025 — classified as 40 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (16 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 40 reports, in the reporter's own words as published by the FDA.

• InjurySep 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT CONTRACTED AN INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22956461 ↗
• InjuryAug 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED THREE TIMES. SURGEON WANTED TO DO A ACETABULAR REVISION AND REMOVED THE LINER, SCREW, AND CUP AND PUT IN A NEW CUP AND A DUAL MOBILITY CONSTRUCT. THE HIP WAS STABLE. THIS PC WAS CREATED TO CAPTURE FIRST DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP. (B)(4) IS THE MOTHER COMPLIANT AND (B)(4) WERE CREATED TO CAPTURE THE FIRST AND SECOND DISLOCATION RESPECTIVELY.

  Patient problems: Joint Dislocation

  MAUDE report 22889091 ↗
• InjuryAug 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED THREE TIMES. SURGEON WANTED TO DO A ACETABULAR REVISION AND REMOVED THE LINER, SCREW, AND CUP AND PUT IN A NEW CUP AND A DUAL MOBILITY CONSTRUCT. THE HIP WAS STABLE. THIS PC WAS CREATED TO CAPTURE SECOND DISLOCATION. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP. (B)(4) IS THE MOTHER COMPLIANT AND (B)(4) WERE CREATED TO CAPTURE THE FIRST AND SECOND DISLOCATION RESPECTIVELY.

  Patient problems: Joint Dislocation

  MAUDE report 22888892 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22810305 ↗
• InjuryJul 31, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED THREE TIMES. SURGEON WANTED TO DO A ACETABULAR REVISION AND REMOVED THE LINER, SCREW, AND CUP AND PUT IN A NEW CUP AND A DUAL MOBILITY CONSTRUCT. THE HIP WAS STABLE. DOI: (B)(6) 2024 DOR: (B)(6) 2025 AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22680685 ↗
• InjuryJul 2, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO CHRONIC DISLOCATION. THE SURGEON TOOK OUT PINNACLE LINER AND 40MM 12/14 TAPER HEAD AND REPLACED THE IMPLANTS WITH CONSTRAINED LINER AND TS HEAD. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22382940 ↗
• InjuryJan 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HEAD/ LINER EXCHANGE DUE TO INFECTION. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI- (B)(6) 2024. DOR- (B)(6) 2025. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21168668 ↗
• InjuryDec 5, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THERE WAS NO SURGICAL DELAY.

  Patient problems: Joint Dislocation

  MAUDE report 20859099 ↗
• InjuryOct 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD RIGHT TOTAL HIP ARTHROPLASTY ON (B)(6) 2024. ON (B)(6) 2024, THE PATIENT DEVELOPED AN INFECTION. THE 60MM +4/40 HEAD LINER AND 40MM +5 TS CERAMIC HEAD WERE REMOVED AND CUP AND STEM WERE EVALUATED TO BE OK TO LEAVE. A NEW LINER AND HEAD BALL WERE PLACED AND THE PATIENT WAS CLOSED. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 20429026 ↗
• InjurySep 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO WOUND DEHISCENCE AND SUPERFICIAL INFECTION. DOI: (B)(6) 2023 DOR: (B)(6) 2023 AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection; Wound Dehiscence

  MAUDE report 17736107 ↗
• InjuryJun 12, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD JUST LOCATING HIP. UNKNOWN SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17107011 ↗
• InjuryNov 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO POSTOPERATIVELY INFECTION. I & D WAS COMPLETED AND SURGEON DECIDED TO EXPLANT AND RE IMPLANT NEW IMPLANTS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR : (B)(6) 2022. AFFECTED SIDE : LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15840303 ↗
• InjuryAug 5, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR LEFT HIP DISLOCATION - INITIAL EVENT IS SERIOUS AND IS CONSIDERED. THERE IS REMOTE POSSIBILITY THAT THE EVENT IS RELATED TO DEVICE AND IS POSSIBLY RELATED TO PROCEDURE. DATE OF IMPLANTATION: (B)(6) 2005. DATE OF REVISION: (B)(6) 2014 (CUP, LINER, AND HEAD). DATE OF EVENT (ONSET): (B)(6) 2021. (LEFT HIP). TREATMENT: CLOSED REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 12281126 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAD INFECTION, I&D PERFORMED. IMPLANTS REMOVED AND ANTIBIOTIC SPACER PLACED. DOI: (B)(6) 2020, DOR: (B)(6) 2020, AFFECTED SIDE: LEFT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10684835 ↗
• InjurySep 24, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF THE MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT HAS EXPERIENCED LEG LENGTH DISCREPANCY. DOI: (B)(6) 2014. DOR: (B)(6) 2015. RIGHT HIP (FIRST REVISION).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Edema; Extraskeletal ossification; No Code Available; Pain; Physical Asymmetry

  MAUDE report 10580643 ↗
• InjuryJun 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS INFECTION. POLY AND HIP BALL EXCHANGED WAS DONE. DOI: UNKNOWN, DOR: (B)(6) 2020, RIGHT SIDE.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10149305 ↗
• InjuryMay 28, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED TO DOCTOR WITH INFECTION. SCHEDULED TWO IRRIGATIONS AND DEBRIDEMENTS. DOCTOR REPLACED OUR HEADLINER AND HEAD PRIOR TO CLOSING. DOI: (B)(6) 2020; DOR: (B)(6) 2020; AFFECTED SIDE: UNKNOWN.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10094881 ↗
• InjuryMar 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A 2 YEAR INFECTED HIP, NOT DEPUY, THAT WAS REMOVED & ANTIBIOTIC SPACER INSERTED ON (B)(6) 2019. PATIENT WAS CLEARED OF INFECTION AND ON (B)(6) 2019 A DEPUY REVISION TOTAL HIP WAS IMPLANTED. IN (B)(6) 2020, THE PATIENT PRESENTED ANOTHER HIP INFECTION AND ALL IMPLANTS WERE REMOVED AND ANTIBIOTIC SPACER IMPLANTED.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9883860 ↗
• InjuryOct 31, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PINNACLE CLAIM LETTER AND MEDICAL RECORDS RECEIVED. CLAIM LETTER ALLEGES SEVERE PAIN, IMPAIRED MOBILITY, STIFFNESS, WALKING DIFFICULTY, MENTAL ANGUISH, DEPRESSION AND FRUSTRATION, SWELLING, NUMBNESS, WEAKNESS AND EMOTIONAL DISTRESS. WITH REGARD TO THIS THE PATIENT IS SEEKING COMPENSATION. AFTER REVIEW OF MEDICAL RECORDS, CLINICAL VISIT REPORTED 4 MONTHS AFTER REVISION PATIENT SLEPT AND DEVELOPED PAIN AND TROCHANTERIC SWELLING, BURSITIS AND HEMATOMA. CLINICAL VISIT ON (B)(6) 2019 LUMP ON THE RIGHT HIP RESULTING TO PAIN, HIP POP IN AND OUT OF PLACE. DOI: B)(6) 2019; DOR: NOT REVISE; RIGHT HIP. THIS COMPLAINT IS LINK TO (B)(4) (1ST REVISION).

  Patient problems: Edema; Hematoma; Host-Tissue Reaction; Hypoesthesia; Joint Dislocation; Limited Mobility Of The Implanted Joint; Pain; Weakness

  MAUDE report 9262078 ↗
• InjuryOct 2, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF, STICKER SHEETS AND IMPLANT RECORDS RECEIVED. PPF INFECTION AND ELEVATED METAL IONS. NO LABS WERE PROVIDED. HEAD IS COMPETITOR, CUP, SCREWS AND STEM WERE REPORTED ON 1ST REVISION. DOI: (B)(6) 2017; DOR: NONE REPORTED; LEFT HIP. STEM, CUP AND SCREWS WERE REPORTED ON (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 9145475 ↗
• InjurySep 16, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF AND STICKER SHEET RECEIVED. PPF ALLEGES DISLOCATION AFTER FIRST REVISION. DOI: (B)(6) 2014, DOR: (B)(6) 2014, (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9072857 ↗
• InjuryAug 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT PRESENTED TO E.R. WITH HIP PAIN. X-RAYS TAKEN IDENTIFIED A MATERIAL FRACTURE AT THE NECK OF THE STEM. NO PATIENT TRAUMA PRECEDING THE FAILURE WAS REPORTED. PPF ALLEGES DISLOCATION WITH CLOSED REDUCTION AND ELEVATED METAL IONS. ADDED LAWYER, LAW FIRM, TICKED LITIGATION BOX AND AN IMPACTED PRODUCT RECORD FOR THE HEAD AND LINER WAS ADDED DUE TO ALLEGED ELEVATED METAL IONS AND DISLOCATION. DOI: (B)(6) 2013 - DOR: SEP 8, 2015 (LEFT HIP) SECOND REVISION. PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 8872212 ↗
• InjuryMay 21, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE LITIGATION RECORDS RECEIVED ALLEGING ELEVATION OF BLOOD COBALT AND CHROMIUM LEVELS, SHARP PAINS, PSOAS TENDINITIS (NEGATIVE FOR INFECTION), METAL REACTION, TRUNNIONOSIS, CICATRIX, PHYSICAL INJURY AND DISABILITY, LACK OF MOBILITY, WEAKNESS OF THE LEFT LEG, DIFFICULTY WALKING LATERALLY, LIMITED MOBILITY AND EMOTIONAL DISTRESS. IT WAS NOTED THAT DURING THE PROCEDURE, THE SURGEON NOTED A LIGHT GREENISH CLOUDY FLUID AND DESTRUCTION OF THE ABDUCTOR MECHANISM. THERE WAS A PSEUDOTUMOR DUE TO THE METAL-ON-METAL REACTION AND A COMPLETE SYNOVECTOMY WAS NEEDED TO DEBRIDE THE HIP OF METAL PARTICLES. THERE WAS GROSS CORROSION WITH BLACK MATERIAL AT THE HEAD-NECK JUNCTION AS WELL AS ON THE HEAD-NECK TAPER. THE LINER IS POLY. DOI: (B)(6) 2006 (STEM), DOI: (B)(6) 2011 (LINER AND HEAD), DOR: (B)(6) 2017, LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Inflammation; Injury; No Code Available; Pain; Scar Tissue; Tissue Damage

  MAUDE report 8627945 ↗
• InjuryMay 9, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED, PFS ALLEGES LOOSENING OF CUP AFTER THE FIRST REVISION. AFTER REVIEW OF MEDICAL RECORDS, OPERATIVE NOTES REPORTED PATIENT'S CUP WAS GROSSLY LOOSE, BUT SHE DID HAVE 1 SCREW IN THE ACETABULAR COMPONENT THAT WAS EXTREMELY WELL FIXED IN PLACE. CLINICAL NOTES STATED THAT HER PREVIOUS MILD OSTEOLYSIS CLEARLY PROGRESSED TO THE POINT OF THIS CUP LOOSENING. DOI: (B)(6) 2014, DOR: (B)(6) 2016, (RIGHT HIP).

  Patient problems: No Code Available; Osteolysis

  MAUDE report 8595125 ↗
• InjuryApr 29, 2019Biocompatibility; Biocompatibility

  PPF ALLEGES PSEUDOTUMOR AND ELEVATED METAL IONS AFTER THE FIRST REVISION. DOI: (B)(6) 2012 - DOR: NOT REPORTED (LEFT HIP).

  Patient problems: Tissue Damage

  MAUDE report 8563195 ↗