NA 1365-07-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 109 adverse event reports that list this exact device (DI 10603295033004), received between Apr 26, 2013 and Sep 30, 2026 — classified as 108 injuries, 1 malfunction.

The most frequently reported specific device problem is “Naturally Worn” (23 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 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 109 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2026Adverse Event Without Identified Device or Use Problem

  Patient problems: Pain

  MAUDE report 50947291 ↗
• InjuryJun 26, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT METAL HEAD AND METAL LINER WERE REMOVED DUE TO OSTEOLYSIS AND TROCHANTERIC FRACTURE AND REPLACED WITH ALTRX LINER AN CERAMIC HEAD. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Osteolysis

  MAUDE report 25638667 ↗
• 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 22889243 ↗
• InjuryAug 25, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD DISLOCATED THREE TIMES. SURGEON WANTED TO DO AN 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: ON (B)(6) 2024, DOR: ON (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 22888925 ↗
• InjuryAug 1, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION, MOST LIKELY DUE TO A PATIENT FALL. DUE TO THE AMOUNT OF METALLOSIS IN THE CAPSULE, IT IS HARD TO RULE THAT OUT. PATIENT ALSO HAS DEMENTIA. DOI: (B)(6) 2009, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Foreign Body Reaction; Joint Dislocation

  MAUDE report 22689131 ↗
• 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 22680687 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND NEEDED REVISION OF A PROSTALAC STEM/LINER AND PLACEMENT OF ANOTHER PROSTALAC. THE FALL FRACTURED BONE AND LOOSENED THE CUP AND STEM. THE PRODUCTS NEEDED TO BE REVISED FOR STABILITY PURPOSES. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21217527 ↗
• InjuryOct 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED AD 20 SEPT 2024. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED DUE TO FAILED INTERNAL PROSTHESIS OF THE LEFT HIP. OPERATIVE NOTES INDICATED PAIN, METALLOSIS, AND FOUND LARGE AREA OF OSTEOLYSIS ON POSTERIOR ASPECT OF THE FEMUR. DOI: (B)(6) 2009, DOR: (B)(6) 2024, LEFT HIP.

  Patient problems: Foreign Body Reaction; Osteolysis; Pain

  MAUDE report 20345952 ↗
• InjurySep 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED: ON (B)(6) 2024, THE PATIENT WAS TREATED OPERATIVELY WITH IRRIGATION AND DEBRIDEMENT, AS WELL AS AN EXCISION/REVISION OF THE PREVIOUS SURGICAL SCAR¿THIS WAS ALL PART OF TREATMENT FOR A SUPERFICIAL WOUND INFECTION OF THE LEFT DIRECT ANTERIOR TOTAL HIP WOUND. THE INCISION WAS RED, SWOLLEN, AND TENDER. CULTURES TESTED POSITIVE FOR MRSA. THE INFECTION WAS ENTIRELY SUPERFICIAL WITH NO DEEP COMMUNICATION TRACTS. NO PRODUCTS WERE REVISED. THE PATIENT WAS SEEN CLINICALLY ON (B)(6) 2024 FOR POST-OPERATIVE FOLLOW-UP. HER WOUND WAS HEALING WELL, AND THE RETENTION SUTURES PLACED ON (B)(6) 2024 WERE REMOVED FROM THE OFFICE.

  Patient problems: Discomfort; Erythema; Post Operative Wound Infection; Swelling/ Edema; Unspecified Infection

  MAUDE report 20323160 ↗
• InjuryAug 5, 2024Adverse 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. JOINT WAS WASHED OUT. HEAD AND POLY WERE SWAPPED FOR NEW ONES OF THE SAME SIZE. THERE WAS NO LOOSENING AND SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19906576 ↗
• InjuryJun 28, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED, AD 18 JUN 2024. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED, DUE TO FAILED LEFT HIP REPLACEMENT WITH EVIDENCE OF PSEUDOTUMOR. DOI: (B)(6) 2009; DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction

  MAUDE report 19635130 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  UPDATE AD 14 JUN 2024 MEDICAL RECORDS RECEIVED: PATIENT UNDERWENT REVISION DUE TO EXTENSIVE METALLOSIS INVOLVING PROXIMAL FEMUR, HIP ABDUCTOR MUSCULATURE, TROCHANTERIC BURSA AND HIP CAPSULE WITH INTACT FIXATION OF DISTAL FEMORAL STEM AND ACETABULAR COMPONENT. THE SURGERY ENTAILED REMOVAL OF THE STEM THROUGH AN EXTENDED TROCHANTERIC OSTEOTOMY, REMOVAL OF THE METAL LINER AS WELL AS REMOVAL OF THE ACETABULAR CUP. EXTENSIVE BROWN COLORED FLUID WAS FOUND IN THE HIP CAPSULE AND METAL DEBRIS WAS DEBRIDED THROUGHOUT THE HIP. A CONSTRAINED LINER WAS USED TO MITIGATE THE POTENTIAL FOR POSTOPERATIVE INSTABILITY AS THE SURGEON DID NOT FEEL A DUAL MOBILITY ARTICULATION WOULD PROVIDE ADEQUATE STABILITY IN THE ABSENCE OF A FULLY INTACT ABDUCTOR MECHANISM. EXTENSIVE ABDUCTOR DAMAGE WAS FOUND. DOI: AUG 01, 2008, DOR: APR 14, 2023, AFFECTED HIP: RIGHT.

  Patient problems: Foreign Body Reaction; Inflammation; Joint Laxity; Unspecified Tissue Injury

  MAUDE report 19610485 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND TO CONFIRM, THAT THERE WERE NO REPORTED SURGICAL DELAY.

  Patient problems: Foreign Body Reaction

  MAUDE report 19089357 ↗
• InjuryOct 18, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO HIP DISLOCATION. NO ADDITIONAL INFORMATION. DOI: (B)(6) 2023, DOR: (B)(6) 2023, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17958451 ↗
• InjuryApr 13, 2023Degraded; Degraded

  LITIGATION RECORDS RECEIVED. AFTER REVIEW, PATIENT WAS REVISED DUE TO THE FOLLOWING REASONS : SUFFERED HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RELEASED BY THE PINNACLE SYSTEM RESULTING IN INJURY. MOREOVER, PATIENT EXPERIENCE INCREASING PAIN, DISCOMFORT, AND SIGNIFICANT MEMORY LOSS. ON (B)(6) 2020, A COBALT CHROMIUM METAL ION TEST SHOWED INCREASED METAL ION LEVELS TO DIAGNOSE COBALT TOXICITY. ON (B)(6) 2020, PLAINTIFF LEARNED HIS METAL ION LEVELS HAD INCREASED AND AN MRI REVEALED FLUID DISTENTION OF THE PSEUDO-CAPSULE AND OSTEOLYSIS OF THE TROCHANTER OF THE RIGHT HIP. HIS MEMORY ISSUES WERE WORSENING.

  Patient problems: Discomfort; Fibrosis; Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Memory Loss/Impairment; Metal Related Pathology; Necrosis; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16739233 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL ADVERSE EVENT RECEIVED FOR ADVERSE TISSUE REACTION AND HIGH COBALT BLOOD LEVELS. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO DEVICE. EVENT IS NOT RELATED TO PROCEDURE. DATE OF REVISION: (B)(6)2023, DATE OF IMPLANT: (B)(6) 2008, DATE OF EVENT: 02 SEP 2022, (RIGHT HIP). TREATMENT: REVISION; HEAD AND LINER WERE REVISED

  Patient problems: Foreign Body Reaction; Metal Related Pathology

  MAUDE report 16713021 ↗
• InjuryMar 20, 2023Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  PATIENT WAS REVISED OF HIP PAIN WITH A SQUEAKING NOISE DUE TO METALLOSIS OF LEFT HIP WITH A MOM BEARING. INCREASED BLOOD LEVELS OF COBALT AND CHROMIUM WAS ALSO NOTED PRIOR TO SURGERY THOUGH NORMAL WHITE BLOOD CELL COUNT. A STRAW COLORED FLUID WAS FOUND IN THE LEFT HIP, THERE WAS ALSO A GRAYISH DISCOLORATION OF THE SYNOVIUM ON THE LEFT HIP. DOI: (B)(6) 2009 DOR: (B)(6) 2020 AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Metal Related Pathology; Pain; Perforation of Vessels; Swelling/ Edema; Unspecified Infection

  MAUDE report 16572067 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH ACTIVE INFECTION. HIP WAS INCISED, DEBRIDED, AND LAVAGED FOLLOWED BY NEW POLY AND FEMORAL HEAD. DOI: (B)(6) 2017, DOR: (B)(6) 2022, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15987202 ↗
• InjuryNov 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED HEAD AND LINER AND REPLACED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15886038 ↗
• InjuryNov 29, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. REMOVED 40MM +8.5 METAL ARTICULEZE HEAD, UPON REMOVAL FOUND SIGNS OF TRUNNIONS. DOCTOR MENTIONED HE BELIEVES THERE IS A BIG ISSUE WITH SUMMIT TAPER AND METAL HEADS. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2012; DOR: (B)(6) 2022; AFFECTED SIDE: RIGHT HIP.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 15878391 ↗
• InjuryAug 17, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL ULTAMET METAL-ON-METAL BILATERAL TOTAL HIP REPLACEMENTS. THE PRIMARY PROCEDURES WERE PERFORMED IN 2008 AND 2009. NO ADDITIONAL INFORMATION IS AVAILABLE. NO SURGICAL DELAY. DOI: 2008, 2009; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT.

  Patient problems: Pain

  MAUDE report 15240497 ↗
• InjuryJul 6, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION OF HEAD AND LINER FROM A PATIENT WHO HAD HIS PRIMARY PROCEDURE DONE ON IN EITHER 2007-2008 BY THE SURGEON. PATIENT WAS UNSTABLE DUE TO THE LIP ON THE LINER BEING POSITION IN THE WRONG POSITION FROM THE PREVIOUS SURGERY. SIDE WAS THE LEFT SIDE. NEW LINER AND HEAD IMPLANTED WITH THE ORIENTATION OF THE LIP POSITION DIFFERENTLY. AWAITING CUSTOMER SERVICE TO SEARCH FOR USAGE OF THE POLY REMOVED. UNABLE TO READ IMPLANT DUE TO DAMAGE OF THE LINER WHEN REMOVING, BUT I WAS ABLE TO GET USED OF THE HEAD. DOI: UNKNOWN, DOR: (B)(6) 2022, UNKNOWN HIP.

  Patient problems: Joint Laxity

  MAUDE report 14932510 ↗
• InjuryJun 30, 2022Naturally Worn; Naturally Worn

  PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS RESULTING TO MUSCLE, TISSUE AND BONE INJURY, METALLOSIS, METAL WEAR, SCAR TISSUE FORMATION, PAIN AND LIMITED ADL. ALSO SUFFERED EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2009; DOR: UNREVISED ; LEFT HIP.

  Patient problems: Adhesion(s); Depression; Distress; Fatigue; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Loss of Range of Motion; Metal Related Pathology; Muscle/Tendon Damage; Osteolysis; Pain; Scar Tissue; Swelling/ Edema; Synovitis; Unspecified Tissue Injury

  MAUDE report 14875636 ↗
• InjuryJun 15, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR EARLY SUSTAINED 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 EVENT: (B)(6) 2022; (RIGHT HIP). TREATMENT: CLOSED REDUCTION/MANIPULATION.

  Patient problems: Joint Dislocation; Low Blood Pressure/ Hypotension

  MAUDE report 14701344 ↗
• InjuryJan 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES TOXIC LEVELS OF METAL IONS IN THE TISSUE, BONE, JOINT, BLOOD STREAM CAUSING DESTRUCTION, PAIN AND EMOTIONAL DISTRESS. DOI: (B)(6) 2008. DOR: (B)(6) 2020. LEFT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Distress; Foreign Body Reaction; Inflammation; Metal Related Pathology; Pain; Physical Asymmetry; Pocket Erosion; Unspecified Tissue Injury

  MAUDE report 13235259 ↗