NA 1365-06-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 174 adverse event reports that list this exact device (DI 10603295032984), received between Jan 17, 2013 and Sep 14, 2026 — classified as 165 injuries, 9 malfunctions.

The most frequently reported specific device problem is “Naturally Worn” (38 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 174 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2026Device Dislodged or Dislocated

  It was reported that the patient was dislocating due to poor cup placement incl/Ante per the doctor. Doctor removed the cup and revised to a new cup with DM.DOI: (b)(6) 2026.DOR: (b)(6) 2026.Affected side: Right Hip.

  Patient problems: Joint Dislocation

  MAUDE report 50752170 ↗
• InjuryAug 22, 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 PAIN IN THEIR HIP, SO THE SURGEON REVISED THE IMPLANT. NO KNOWN INFECTION WAS PRESENT. THERE WAS NO DELAY IN SURGERY. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 22871455 ↗
• InjuryJul 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT PRESENTED WITH A PINNACLE METAL ON METAL MODULAR LINER AND A METAL FEMORAL HEAD. SURGEON ELECTED TO DO A LINER AND HEAD EXCHANGE, WHEREBY REPLACING THE METAL-ON-METAL CONSTRUCT WITH A POLYETHYLENE LINER AND CERAMIC HEAD. THE REASON FOR THE REVISION WAS DUE TO THE PATIENT HAVING HIGH LEVELS OF METAL IONS IN HER BLOOD. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Metal Related Pathology

  MAUDE report 22674404 ↗
• InjuryMar 18, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT HAD PREVIOUS TOTAL HIP ARTHROPLASTY ON THE RIGHT HIP AND HAD DISLOCATED SO THE PINNACLE LINER WAS REMOVED AND REPLACED WITH A PINNACLE DUAL MOBILITY LINER. THE METAL 40+5 HEADBALL WAS REMOVED AS WELL. NO SURGICAL DELAY. DOI: UNKNOWN. DOR: (B)(6) 2025. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 21632007 ↗
• InjuryAug 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENTS RECEIVED FOR INFECTION - DEEP DEVICE AND PROCEDURE(RELATEDNESS) DEVICE RELATED: REMOTE POSSIBILITY PROCEDURE RELATED: PROBABLY DATE OF IMPLANT: (B)(6) 2024 DATE OF REVISION: (B)(6) 2024 DEVICE LOCATION: LEFT TREATMENT/IMPACT: REVISION.

  Patient problems: Adhesion(s); Impaired Healing; Pain; Post Operative Wound Infection; Unspecified Infection

  MAUDE report 20052158 ↗
• InjuryAug 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A HEAD AND LINER EXCHANGE WITH IRRIGATION AND DEBRIDEMENT (I&D) FOR INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 19982551 ↗
• InjuryJul 10, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION WAS RECEIVED STATING THAT THERE WAS NO SURGICAL DELAY REPORTED.

  Patient problems: Joint Dislocation

  MAUDE report 19712379 ↗
• InjuryJun 25, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT HAD A REVISION SURGERY FOR METALLOSIS PAIN. THE PATIENT HAD A CONVERSION TO POLY ON CERAMIC. DOI: UNKNOWN, DOR: ON (B)(6) 2024, AFFECTED SIDE: LEFT HIP.

  Patient problems: Foreign Body Reaction; Pain

  MAUDE report 19605650 ↗
• InjuryJun 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  STUDY NO: DOTS CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION. EVENT IS SERIOUS AND IS CONSIDERED SEVERE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT:(B)(6) 2024 DATE REVISION: (B)(6) 2024 DATE OF EVENT: 05 JUN 2024 (LEFT HIP). TREATMENT: REVISION; PRODUCTS REVISED UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 19537813 ↗
• MalfunctionApr 16, 2024Naturally Worn; Naturally Worn

  PC WAS CREATED DUE TO PATIENT ALLEGED TRACES OF METAL SHAVINGS IN HIS BLOOD LEFT HIP. DOI: #: (B)(6) 2009. DOR: UNKNOWN. RIGHT HIP. BILATERAL THIS PC WAS LINKED TO (B)(4) LEFT HIP.

  Patient problems: Insufficient Information

  MAUDE report 19119309 ↗
• InjuryJan 23, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT HAD A RIGHT TOTAL HIP DONE BY THE SURGEON SOMETIME IN 2012. THIS WAS DONE WITH A TRILOCK STEM, PINNACLES CUP AND METAL ON METAL 40X 58 LINER WITH A +5 40MM METAL HEAD. PATIENT WAS HAVING PAIN AND SWELLING AND WAS BROUGHT IN FOR HEAD AND LINER REVISION. A NEW 48X58 +4 10 DEGREE LINER WAS IMPLANTED WITH A 40MM +5 TS CERAMIC HEAD. DOI: (B)(6) 2012. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain; Swelling/ Edema

  MAUDE report 18562972 ↗
• InjuryNov 1, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO PAIN. SURGICAL DELAY WAS UNKNOWN. DOI: UNKNOWN. DOR: (B)(6 2023 AFFECTED SIDE: LEFT HIP.

  Patient problems: Pain

  MAUDE report 18048180 ↗
• InjuryOct 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HO REMOVAL AND SCIATIC NEUROLYSIS. HEAD AND LINER WAS EXCHANGED. DOI: (B)(6) 2022. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Extraskeletal ossification; Nerve Damage

  MAUDE report 17971216 ↗
• InjuryAug 23, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. REMOVED LINER AND HEAD FOR NEW IMPLANTS AFTER WASHING OUT. DOI: JUL 13, 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17606849 ↗
• InjuryJul 26, 2023Naturally Worn; Naturally Worn

  ADDITIONAL INFORMATION WAS RECEIVED: PLAINTIFF WAS IMPLANTED WITH A MOM PINNACLE SYSTEM IN PLAINTIFFS HIP ON (B)(6) 2009. PATIENT SUFFERED HEAVY METAL POISONING, INJURY AND REQUIRING SURGERY TO REMOVE THE DEFECTIVE HIP REPLACEMENTS. PLAINTIFF WAS FORCED TO UNDERGO SURGICAL REMOVAL DUE TO HEAVY METAL POISONING ON (B)(6) 2022. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PINNACLE HIP, PLAINTIFF WAS REQUIRED TO UNDERGO SURGICAL REMOVAL OF THE DEFECTIVE SYSTEM, SUFFERED INJURY TO HIS MUSCLE AND TISSUE, SUFFERED ADDITIONAL SCAR TISSUE FORMATION, AND NOW HAS A HIP REPLACEMENT WITH DECREASED LONGEVITY. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PINNACLE HIP REPLACEMENT, PLAINTIFF SUFFERED INJURIES, INCLUDING BUT NOT LIMITED TO SIGNIFICANT PAIN, INJURY CAUSED BY METALLOSIS, METAL WEAR, AND METAL POISONING. PLAINTIFF EXPECTS TO CONTINUE SUFFERING SUCH INJURIES IN THE FUTURE BECAUSE OF THE INJURIES RECEIVED FROM THE PINNACLE. AS A DIRECT AND PROXIMATE RESULT OF THE DEFECTIVE PINNACLE, PLAINTIFF EXPERIENCED EMOTIONAL TRAUMA AND DISTRESS AND IS LIKELY TO EXPERIENCE EMOTIONAL TRAUMA AND DISTRESS IN THE FUTURE.

  Patient problems: Adhesion(s); Distress; Foreign Body Reaction; Metal Related Pathology; Pain; Unspecified Tissue Injury

  MAUDE report 17396842 ↗
• InjuryMar 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT REQUEST: I AM LOOKING TO SPEAK TO SOMEONE ABOUT MY RECENT HIP REVISION SURGERY TO REMOVE THE DEPUY ASR ITEM. THE CONTACT INFORMATION FOR US ASR PATIENTS WHO HAVE HAD SURGERY TO REMOVE THEIR ASR HIP AFTER (B)(6) 2013, DOES NOT SEEM TO BE ACTIVE, THE PHONE NUMBER SAYS DISCONNECTED, AND THE WEBSITE (B)(6) CAN NOT BE REACHED. (B)(6) 2023: SPOKE WITH PATIENT VIA PHONE. HE INDICATED HIS RIGHT HIP WAS IMPLANT WITH ASR IN (B)(6) 2010 AND UNDERWENT A REVISION IN (B)(6) 2023 FOR PAIN, METALLOSIS, AND STEM LOOSENING. PATIENT IS SEEKING COMPENSATION FOR THE PAIN. PATIENT WILL BE EMAILED (WITHIN ECM) A CONTACT FOR COMPENSATION REQUEST. MEDICAL RECORDS. ON (B)(6) 2023 RIGHT METALLOSIS, FAILED ASR DEPUY SECONDARY TO METALLOSIS PATIENT WAS REVISED DUE TO INSULT WITH TRUNNIONOSIS WITH THE FAILED ASR. THE PATIENT HAD ELEVATED METAL LABS OF PSEUDOTUMOR. THE ACETABULAR COMPONENT WAS NEUTRAL INVERSION. THE FEMORAL STEM WAS COMPLETELY LOOSE AT LEAST EXPECTEDLY LOOSE PRIOR TO SURGERY. DOI: (B)(6) 2010; DOR: (B)(6) 2023; RIGHT HIP.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Pain

  MAUDE report 16572243 ↗
• InjuryMar 16, 2023Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. ON (B)(6) 2009, THE PATIENT RECEIVED A PRIMARY RIGHT TOTAL HIP REPLACEMENT WITH METAL-ON-METAL ARTICULATION TO ADDRESS DEGENERATIVE JOINT DISEASE USING AN ANTERIOR APPROACH. DEPUY PINNACLE GRIPTION CUP WAS IMPLANTED IN THE ACETABULUM WITH ONE SCREW, AND A PRESS-FIT TRILOCK INGROWTH FEMORAL STEM WAS PLACED IN THE FEMORAL CANAL. METAL ON THE METAL LINER AND HEAD WERE PLACED WITHOUT ISSUE. NO COMPLICATIONS WERE REPORTED. ON (B)(6) 2021, THE PATIENT RECEIVED AN MRI OF THE RIGHT HIP, IDENTIFYING A LARGE FLUID COLLECTION AND ALVAL, AND PROXIMAL FEMORAL OSTEOLYSIS. ON (B)(6) 2021, THE PATIENT WAS REVISED TO ADDRESS PSEUDOTUMOR AND ALVAL. THERE WAS EVIDENCE OF EXTENSIVE SCARRING, AND METALLOSIS AT THE HEAD-NECK JUNCTION. THE FEMORAL NECK SHOWED EVIDENCE OF TRUNNIONOSIS. THE SURGEON NOTED THERE WAS BONE LOSS OF APPROXIMATELY 20% OF THE POSTERIOR WALL BEHIND THE ACETABULAR SHELL. DESPITE THIS, THE CUP WAS WELL-FIXED AND IN A GOOD POSITION. THE FEMORAL COMPONENT WAS FOUND TO BE WELL FIXED AND DEEMED IN GOOD CONDITION FOR REVISION OF HEAD AND LINER ONLY. A POLYETHYLENE LINER AND CERAMIC HEAD WERE IMPLANTED. THERE WERE NO REPORTED COMPLICATIONS. ON (B)(6) 2021, AN ULTR

  Patient problems: Discomfort; Foreign Body Reaction; Hypersensitivity/Allergic reaction; Metal Related Pathology; Osteolysis; Pain; Scar Tissue; Seroma; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 16553822 ↗
• InjuryJan 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED INDICATED THAT THE PATIENT WAS REVISED TO ADDRESS A HEMATOMA. DURING THE SURGERY, IT WAS NOTICED THAT THE PATIENT HAD A BONE FRACTURE AND CABLES WERE PLACED. ONLY THE FEMORAL HEAD WAS REVISED.

  Patient problems: Hematoma

  MAUDE report 16252578 ↗
• InjuryJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL RIGHT HIP. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 16184078 ↗
• InjuryJan 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO INFECTION. I&D AND POLY EXCHANGE WERE PERFORMED. DOI: ON (B)(6) 2022. DOR: ON (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 16124346 ↗
• InjuryDec 15, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL METAL-ON-METAL HIP. NO ADDITIONAL INFORMATION IS AVAILABLE. THERE WAS NO REPORTED LOOSENING. THERE WAS NO REPORTED SURGICAL DELAY. DOI: (B)(6) 2009. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 15987337 ↗
• MalfunctionSep 27, 2022Device Damaged Prior to Use; Device Damaged Prior to Use

  IT WAS REPORTED THAT THE FINAL 40 +5 METAL HEAD WAS OPENED. THE SCRUB TECH NOTICED IT HAD SCRATCHES. THE SURGEON LOOKED AND CONFIRMED THERE WERE SCRATCHES ON TOP, SIDE, AND UNDERNEATH. THE REP THEN LOOKED AT HEAD AND CONFIRMED DEFECTS. THE HEAD WAS NOT IMPLANTED, AND THE 2ND HEAD WAS OPENED AND LOOKED NORMAL. THE SURGERY WAS DELAYED BY 1 MINUTE.

  Patient problems: Insufficient Information

  MAUDE report 15494483 ↗
• InjuryApr 28, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO PAINFUL HIP WITH METAL ON METAL ARTICULATION. DOI: UNKNOWN. DOR: (B)(6) 2022. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Pain

  MAUDE report 14243738 ↗
• InjuryApr 12, 2022Naturally Worn; Noise, Audible; Naturally Worn; Noise, Audible

  MOM PINNACLE LITIGATION RECEIVED. PATIENT ALLEGES PAIN, ELEVATED METAL ION, METAL DEBRIS, PSEUDOTUMOR, INJURY, TISSUE DESTRUCTION, BONE DESTRUCTION, AND EMOTIONAL DISTRESS. DOI: (B)(6) 2011. DOR: (B)(6) 2021. (RIGHT HIP).

  Patient problems: Adhesion(s); Ambulation or Postural Difficulties; Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Cramp(s) /Muscle Spasm(s); Discomfort; Distress; Hypersensitivity/Allergic reaction; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Necrosis; Pain; Scar Tissue; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 14084175 ↗
• InjuryMar 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT METAL LINER WAS REMOVED AND REPLACEMENT WITH POLY DUE TO ELEVATED METAL IONS AND PAIN. NO ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY. DOI: (B)(6), 2008. DOR: (B)(6), 2022. AFFECTED SIDE: LEFT HIP.

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

  MAUDE report 13790330 ↗