NA 1365-09-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 34 adverse event reports that list this exact device (DI 10603295033042), received between Aug 18, 2017 and Jan 6, 2026 — classified as 33 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 34 reports, in the reporter's own words as published by the FDA.

• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

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

  Patient problems: Unspecified Infection

  MAUDE report 23977911 ↗
• InjuryAug 14, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 22810304 ↗
• InjuryJun 17, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION HIP SURGERY DUE TO INSTABILITY. STEM WAS NOT REVISED. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Laxity

  MAUDE report 22231997 ↗
• MalfunctionMay 9, 2025Degraded; Degraded

  (B)(6) FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK 10 FOR Q1 OF 2025. (B)(6) IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REMOVAL OF SPACER AFTER INFECTION TREATMENT. REIMPLANTATION OF FINAL IMPLANTS. AT REMOVAL THERE WAS CORROSION ON THE FEMORAL HEAD.

  Patient problems: Insufficient Information

  MAUDE report 21993171 ↗
• InjuryFeb 13, 2025Degraded; Naturally Worn; Degraded; Naturally Worn

  PINNACLE METAL ON METAL MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS TRUNNIONOSIS, METAL ON METAL BEARING WEAR, HIP PAIN, ELEVATED METAL IONS. OPERATIVE NOTE REPORTED DIFFUSE METALLOSIS WITH SYNONVIAL STAINING, CORROSION ON THE TRUNNION AND WITHIN THE INTERNAL BORE OF THE FEMORAL HEAD. CLINICAL VISIT ON (B)(6) 2020 REPORTED ABDUCTOR DEFICIENCY, DAMAGE FROM TRICHINOSIS DUE TO ELEVATED METAL IONS, ADVERSE REACTION TO METAL DEBRIS, MILD TRENDELENBURG GAIT, FLUID AROUND THE INSERTION OF GLUTEUS MEDIUS TENDON WITH ADDITIONAL LOSS OF A PORTION OF THE GM TENDON. MRI REPORTED EDEMA WITHIN THE GREATER TROCHANTER AND ABDUCTOR TENDONS. PATIENT HAD RECEIVED PRIMARY LEFT TOTAL HIP ARTHROPLASTY IN 2001. IN 2008, PATIENT'S LEFT HIP WAS REVISED TO ADDRESS ACETABULAR LINER IMPLANT POLYETHYLENE BEARING WEAR, ACETABULAR OSTEOLYSIS/OSTEOLYTIC CYSTS, INSTABILITY/SUBLUXATION AND INTERFACE FAILURE/LOOSENING OF THE INGROWTH CUP AT BONE TO IMPLANT INTERFACE. PRODUCTS WERE CHANGED TO DEPUY CUP AND METAL-ON-METAL BEARING PRODUCTS. POST-OPERATIVELY, PATIENT BEGAN EXPERIENCING PAIN OVER THE GREATER TROCHANTER, WHICH WORSENED AFTER HE FELL DURING HIKING IN (B

  Patient problems: Ambulation or Postural Difficulties; Foreign Body Reaction; Metal Related Pathology; Pain; Swelling/ Edema

  MAUDE report 21376994 ↗
• InjuryJan 8, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION, EVERYTHING TAKEN OUT AND A PROSTALAC PUT IN. DOI: (B)(6) 2021. DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18464183 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE HEAD LINER WAS CHANGED FOR SUSPECTED INFECTION, NO WAY TO CONFIRM INFECTION STATUS. IT WAS UNKNOWN, IF THERE WAS A SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE- LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18048857 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL LEFT HIP AND METALLOSIS OF LEFT HIP. IT WAS UNKNOWN ABOUT SURGICAL DELAY. DOI: (B)(6) 2009. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17965306 ↗
• InjuryAug 7, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE MOM CLAIM LETTER RECORD RECEIVED. CLAIM LETTER ALLEGES PAIN, DISCOMFORT, DIFFICULTY WALKING, METALLOSIS, PERMANENT TISSUE AND MUSCLE LOSS, REDUCED ABILITY TO WORK, LOSS OF A NORMAL LIFE, AND ELEVATED METAL IONS. HOWEVER, LAB RESULTS SHOWS BELOW 7 PPB. MRI SUGGEST ADVERSE LOCAL TISSUE REACTION. THE PATIENT IS SEEKING COMPENSATION FOR ALL THE INJURIES EXPERIENCED. DOI: (B)(6) 2012; DOR: UNREVISED ; RIGHT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Foreign Body Reaction; Loss of Range of Motion; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 17471921 ↗
• InjuryNov 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO SUSPECTED INFECTION. NO WAY TO CONFIRM INFECTION. DOI: (B)(6) 2022; DOR: (B)(6) 2022; AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15798911 ↗
• InjuryOct 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED DUE TO DISLOCATION. THERE WAS REMOVAL OF HEAD AND LINER. IT WAS REPLACED WITH A HEMI HEAD FOR BETTER STABILITY. THERE WAS NO SURGICAL DELAY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 15589571 ↗
• InjuryOct 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO I&D WITH HEAD AND LINER CHANGE FOR SUSPECTED INFECTION. NO WAY TO CONFIRM PRESENCE OR ABSENCE OF INFECTION. THERE WAS NO DELAY IN SURGERY. DOI: (B)(6) 2022. DOR: (B)(6) 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 15538527 ↗
• InjuryJul 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAIN. DOI- UNKNOWN; DOR- (B)(6) 2022; AFFECTED SIDE- RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14976379 ↗
• InjuryMar 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) CLAIM LETTER RECORD RECEIVED. CLAIM LETTER ALLEGES PAIN, DISCOMFORT, DIFFICULTY WALKING, METALLOSIS, PERMANENT TISSUE AND MUSCLE LOSS, REDUCED ABILITY TO WORK, LOSS OF A NORMAL LIFE, AND ELEVATED METAL IONS. HOWEVER, LAB RESULTS SHOWS BELOW 7 PPB. MRI SUGGEST ADVERSE LOCAL TISSUE REACTION. THE PATIENT IS SEEKING COMPENSATION FOR ALL THE INJURIES EXPERIENCED. DOI: (B)(6) 2011; DOR: (B)(6) 2021 ; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Discomfort; Foreign Body Reaction; Joint Laxity; Loss of Range of Motion; Pain; Pocket Erosion; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 13838605 ↗
• InjurySep 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION. NO SURGICAL DELAY. DOI: (B)(6) 2021, DOR: (B)(6) 2021, LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 12526376 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS AN INFECTION OF UNKNOWN ETIOLOGY. ALL COMPONENTS WERE EXPLANTED FOR A 2 STAGE REVISION. THE ACETABULAR COMPONENTS WERE COMPETITOR. DOI: (B)(6) 2020 DOR: (B)(6) 2021 RIGHT HIP.

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

  MAUDE report 12122537 ↗
• InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT CONTINUING CARE FOR THE INFECTED HIP. THE SURGEON EXCHANGED MODULAR IMPLANTS WHILE EXTRACTING ANTIBIOTIC BEADS. DOI: (B)(6) 2020, DOR: (B)(6) 2020, RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 10683119 ↗
• InjuryMar 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED TO ADDRESS HIP PAIN. METAL ON METAL. DOI: 2009; DOR: (B)(6) 2020; RIGHT HIP.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; No Code Available; Pain; Swelling/ Edema

  MAUDE report 9815021 ↗
• InjuryJan 6, 2020Adverse 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 WITH THE REMOVAL OF SUMMIT POROUS STEM AND HEAD. ACETABULAR SHELL AND POLY WERE COMPETITOR. DOI: UNKNOWN; DOR: (B)(6) 2019; RIGHT HIP.

  Patient problems: No Code Available; Unspecified Infection

  MAUDE report 9553671 ↗
• InjuryNov 27, 2019Corroded; Naturally Worn; Adverse Event Without Identified Device or Use Problem; Corroded; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT HAS PAIN AND BONE LOSS. X-RAY RESULTS MARK OSTEOLYSIS. THE PATIENT WAS THEN REVISED FOR FAILED LEFT TOTAL HIP REPLACEMENT SECONDARY TO METAL-METAL DISEASE. OPERATIVE NOTES REPORTED THAT THERE WERE NOTED TO BE CORROSIVE CHANGES AT THE NECK AND HEAD JUNCTION. THERE WERE NOTED TO BE CORROSIVE CHANGES AT THE NECK AND HEAD JUNCTION AS WELL AS A PSEUDO TUMOR REACTION OR CORROSION CHANGES AT THE JUNCTION OF LINER AND SHELL. THERE WAS A SIGNIFICANT AMOUNT OF PSEUDO TUMOR IN THE AREA OF LYSIS.

  Patient problems: Extraskeletal ossification; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Inflammation; Injury; Limited Mobility Of The Implanted Joint; Loss of Range of Motion; Metal Related Pathology; Necrosis; No Code Available; Osteolysis; Pain; Tissue Damage; Unspecified Tissue Injury

  MAUDE report 9385842 ↗
• InjuryNov 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS DISLOCATION. PE WAS DEFORMED UPON RELOCATION ON CLOSED REDUCTION. DOI: (B)(6) 2016; DOR; (B)(6) 2019; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9376187 ↗
• InjuryApr 25, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LITIGATION ALLEGES INFECTION AND ELEVATED METAL IONS. DOI: (B)(6) 2013 - DOR: (B)(6) 2014, (RIGHT HIP); DOI: (B)(6) 2009, (STEM, CUP, AND 2 SCREWS).

  Patient problems: No Code Available; Test Result; Unspecified Infection

  MAUDE report 8549069 ↗
• InjuryApr 12, 2019Biocompatibility; Biocompatibility

  THE PPF AND STICKER SHEETS RECORD RECEIVED. PPF ALLEGES INFECTION AND ELEVATED METAL IONS AFTER FIRST REVISION. DOI: (B)(6) 2007, (STEM); DOI: (B)(6) 2014, (HEAD); DOR: NONE REPORTED, (RIGHT HIP). PLEASE SEE (B)(4) FOR THE FIRST REVISION.

  Patient problems: Test Result; Unspecified Infection

  MAUDE report 8508570 ↗
• InjuryApr 8, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION WITH OPEN AND CLOSED REDUCTION. DOI: (B)(6) 2011 - DOR: NONE REPORTED (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 8491631 ↗
• InjuryApr 4, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES DISLOCATION AND INFECTION. PFS ALLEGES PAIN AND INFECTION. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED DUE TO DISLOCATION AND METALLOSIS DUE TO METAL IMPINGEMENT ON LOCKING RING. OPERATIVE NOTES INDICATES WEAR, EROSION AND FRACTURE ON THE LOCKING RING. THERE WERE NO MENTION OF INFECTION. DO: (B)(6) 2013; DOR: (B)(6) 2015; RIGHT HIP.

  Patient problems: Joint Dislocation; No Code Available; Pain; Tissue Damage

  MAUDE report 8482386 ↗