NA 1365-08-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 43 adverse event reports that list this exact device (DI 10603295033028), received between Jul 11, 2017 and Feb 11, 2026 — classified as 42 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (11 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 43 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT EXPERIENCED AN INFECTION OF HIP JOINT. IT INVOLVED A METAL ON METAL HIP. HEAD AND LINER WERE EXCHANGED. HIP WAS WASHED OUT AND ANTIBIOTICS PLACED. NO PATIENT INJURY OR DELAY. DOI: (B)(6) 2010. DOR: (B)(6) 2026. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24316678 ↗
• InjuryJul 17, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATENT WAS REVISED DUE TO DISLOCATION. CONSTRAINED LINER WAS IMPLANTED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 22533074 ↗
• InjurySep 27, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION - INITIAL DEVICE RELATEDNESS: POSSIBLY PROCEDURE RELATEDNESS: REMOTE POSSIBILITY DATE OF EVENT: 12/SEP/2024 DATE OF IMPLANT: NO INFORMATION PROVIDED DATE OF REVISION: NO INFORMATION PROVIDED DEVICE LOCATION: LEFT. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Joint Dislocation

  MAUDE report 20326592 ↗
• InjuryAug 6, 2024Naturally Worn; Naturally Worn

  PINNACLE MOM MEDICAL RECORDS RECEIVED. AFTER REVIEW OF THE MEDICAL RECORDS THE PATIENT WAS REVISED TO ADDRESS METALLOSIS, HIP PAIN AND LIMITED ADL. OPERATIVE NOTE REPORTED. THERE WAS A SMALL AMOUNT OF MILDLY CLOUDY FLUID NOTED ON ENTRY TO THE HIP JOINT, SCAR TISSUE IN THE HIP JOINT WITH MILD EVIDENCE TO GRAY STAINING FROM METAL DEBRIS. THERE WAS A SMALL AMOUNT OF TISSUE AROUND THE LINER WITHIN THE CUP. HEAD AND LINER REVISION. CLINICAL VISIT ON (B)(6) 2023 HAD IMPRESSION OF OSTEOLYSIS, BURSITIS OR TENDINITIS DOI: (B)(6) 2008; DOR: (B)(6) 2023; RIGHT HIP.

  Patient problems: Adhesion(s); Foreign Body Reaction; Inflammation; Loss of Range of Motion; Muscle/Tendon Damage; Pain; Scar Tissue; Swelling/ Edema

  MAUDE report 19919248 ↗
• InjuryApr 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INSTABILITY. THERE WAS NO LOOSENING REPORTED. NO SURGICAL DELAY WAS REPORTED. DOI: UNKNOWN, DOR: (B)(6) 2023, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Laxity

  MAUDE report 16822993 ↗
• InjuryApr 11, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD HIS LEFT HIP REPLACED SOME TIME AGO. THE PATIENT HAS A TRILOCK STEM, PINNACLE CUP, ULTAMET METAL LINER, AND A METAL FEMORAL HIP BALL. THE PATIENT WAS CONSULTING WITH HIS SURGEON REGARDING ELEVATED IONS IN SERUM AND MADE THE DECISION TO HAVE HIS HIP CONSTRUCT REVISED. THE PINNACLE CUP WAS LEFT IN SITU AND THE TRILOCK STEM, HIP BALL, AND METAL LINER WERE ALL EXPLANTED. A NEW POLYETHYLENE LINER WAS IMPLANTED ALONG WITH A NEW RECLAIM HIP STEM AND FEMORAL HIP BALL. THERE WAS LOOSENING REPORTED AT THE TRILOCK STEM. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE : LEFT HIP . THERE WAS NO SURGICAL DELAY.

  Patient problems: Metal Related Pathology

  MAUDE report 16712572 ↗
• InjuryFeb 21, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED DUE TO DISLOCATION. THIS PATIENT HAD HIS HIP REVISED SOMETIME AGO BY THE SURGEON. THE PATIENT HAS A 7 HIGH SUMMIT STEM, A 62MM PINNACLE CUP , A CONSTRAINED LINER, AND A 40MM +12 HIP BALL. THE CAT # AND LOT # FOR THE STEM, PINNACLE CUP, AND CONSTRAINED LINER ARE UNKNOWN. THE DATE OF THE REVISION IS UNKNOWN . THE PATIENT HAD DISLOCATED AND SURGEON DID AN OPEN REDUCTION WHERE THE 40MM +12 HIP BALL AND CONSTRAINED LINER WERE EXPLANTED AND REPLACED WITH A NEW FEMORAL HEAD AND CONSTRAINED LINER AND THE HIP WAS REDUCED. DOI: UNKNOWN. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 16413912 ↗
• InjuryDec 6, 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: LEFT HIP.

  Patient problems: Pain

  MAUDE report 15925403 ↗
• InjuryOct 27, 2022Naturally Worn; Naturally Worn

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES BONE FRACTURE AND INFECTION. IT IS UNKNOWN WHICH BONE WAS FRACTURED. DOI: (B)(6) 2010 - DOR: (B)(6) 2012 (LEFT HIP).

  Patient problems: Foreign Body Reaction; Hemorrhage/Blood Loss/Bleeding; Unspecified Infection

  MAUDE report 15680224 ↗
• InjuryOct 11, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT THE PATIENT HAD A TOTAL HIP IMPLANTED IN 2009 BY DR PD. THE STEM WAS LOOSE. STEM, HEAD AND METAL LINER WERE EXPLANTED. A DEPUY STANDARD POLY WAS USED, AND A COMPETITORS REVISION FEMUR AND HEAD WERE RE-IMPLANTED. I HAVE NO OTHER INFORMATION ON THIS CASE. UPDATE AD 6 SEP 2022: IN RELATION TO AEI NOTE A-7896809, (B)(4) PINNACLE MOM LITIGATION RECORD RECEIVED. LITIGATION ALLEGES HEAVY METAL POISONING FROM THE TOXIC HEAVY METALS, METALLOSIS, METAL DEBRIS RESULTING TO INJURY, LEFT HIP PAIN AND LIMITED ADL. X-RAYS SHOWED OSTEOLYTIC LESIONS AROUND THE FEMORAL COMPONENT. REVISION NOTE REPORTED SURGEON ENCOUNTERED A RUSH OF DARK COLORED JOINT FLUID, SIGNIFICANT BONE LOSS AND METALLOSIS, TOXIC HEAVY METAL ION COBALT AND CHROMIUM POISONING. PLAINTIFF ALSO EXPERIENCED EMOTIONAL TRAUMA AND DISTRESS. DOI: (B)(6) 2009; DOR: (B)(6) 2022 ; LEFT HIP.

  Patient problems: Ambulation or Postural Difficulties; Distress; Fatigue; Foreign Body Reaction; Joint Laxity; Loss of Range of Motion; Metal Related Pathology; Muscular Rigidity; Osteolysis; Pain; Swelling/ Edema; Unspecified Tissue Injury

  MAUDE report 15581532 ↗
• InjuryMay 24, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  REVISION COMPLETED DUE TO SEPTIC HIP. WASHOUT WAS COMPLETED. HEAD AND LINER WERE EXCHANGED. NO SURGICAL DELAY. DOI: UNKNOWN .DOR: (B)(6), 2022. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 14490187 ↗
• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE DOCTOR SAID THE PATIENT REQUIRED SOFT TISSUE REPAIR. THE CUP AND STEM WERE CHECKED AND NOTED AS STABLE. HEAD AND LINER WERE CHANGED. DOI: (B)(6) 2020 - DOR: (B)(6) 2021 (UNKNOWN SIDE).

  Patient problems: Unspecified Tissue Injury

  MAUDE report 12050100 ↗
• InjuryDec 16, 2020Naturally Worn; Naturally Worn

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED PAIN, METALLOSIS DEBRIS IN THE JOINT, ELEVATED METAL IONS LEVELS, SCAR IN PSEUDOCAPSULE, SOME LYSIS IN THE AREA OF THE TROCHANTER AND AREA OF ANTERIOR-SUPERIOR WALL OF THE CUP. CUP WAS REMOVED WITH MINIMAL BONE LOSS AND WAS IN RETROVERTED POSITION. DOI: (B)(6) 2008 DOR: (B)(6) 2020 RIGHT HIP. (B)(4).

  Patient problems: Adhesion(s); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Foreign Body Reaction; Osteolysis; Pain

  MAUDE report 11021541 ↗
• InjuryNov 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PC HAS BEEN RE-OPENED DUE TO RECEIPT OF AUDIT CORRECTION, WHICH REQUESTED TO CAPTURE ELEVATED METAL ION ALLEGATIONS FOR THE REVISION ON (B)(6) 2020. HIP BONE IS NOW MUSH. MUSCLE IS DESTROYED WAS NOTED TO BE DUE TO THE ELEVATED COBALT LEVELS.

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

  MAUDE report 10811278 ↗
• InjuryOct 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IN ADDITION TO WHAT PREVIOUSLY ALLEGED, AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED DUE TO FAILED LEFT HIP REPLACEMENT WITH METALLOSIS. UPON ENTERING THE DEEP JOINT BY EXCISING SOME OF THE ANTERIOR CAPSULE, THE TYPICAL CREAMY YELLOWISH TYPE FLUID WAS ENCOUNTERED. PSEUDOTUMOR HAS BEEN DIAGNOSED.

  Patient problems: Distress; Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Swelling/ Edema

  MAUDE report 10628376 ↗
• InjurySep 15, 2020Corroded; Degraded; Corroded; Degraded

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED DUE TO PAIN, ELEVATED COBALT AND CHROMIUM LEVEL, FAILED LEFT TOTAL HIP ARTHROPLASTY WITH EVIDENCE OF METALLOSIS AND CORROSION AT THE HEAD TAPER JUNCTION. REVISION NOTE REPORTED A GRAY METAL STAINING ABOUT THE CAPSULE. THERE WAS METAL STAINING AND CORROSIVE CHANGES IN THE TRUNNION OF THE STEM. THE CUP WAS WELL FIXED. LAB RESULT FOR COBALT AND CHROMIUM LEVEL ARE ABOVE 7 PPB. MRI DOES SHOW PSEUDOTUMOR ABOUT THE LEFT HIP. DOI: (B)(6) 2010 (LINER, HEAD) DOI: (B)(6) 2007 (STEM) DOR: (B)(6) 2019 LEFT HIP, SECOND REVISION.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; No Code Available; Pain; Test Result

  MAUDE report 10535904 ↗
• InjuryMar 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT WAS REVISED TO ADDRESS SUBLUXATION DURING EXTENSION. DOI: (B)(6) 2010, DOR: (B)(6) 2011 (LEFT HIP). UPDATE AD 27 SEP 2019: (B)(4) HAS BEEN RE-OPENED UNDER (B)(4) DUE TO RECEIPT OF UNF AND MEDICAL RECORDS. AFTER REVIEW OF MEDICAL RECORDS, IT WAS INDICATED THAT THE PATIENT DEVELOPED SENSATIONS OF SUBLUXATION AS WELL AS DISLOCATION AND INSTABILITY AS WELL AS INCREASING PAIN IN THE HIP. THE PATIENT WAS THEN REVISED FOR FAILURE OF RIGHT TOTAL HIP ARTHROPLASTY. OPERATIVE NOTES REPORTED A BROWNISH SLUDGE-LIKE MATERIAL. ADDED LAWYER, LAW FIRM, REVISION HOSPITAL AND PATIENT DOB. UPDATED PATIENT INITIALS. CORRECTED AFFECTED SIDE. DOI: (B)(6) 2010, DOR: (B)(6) 2011; RIGHT HIP. PLEASE SEE (B)(4) FOR THE RIGHT HIP 1ST REVISION.

  Patient problems: Joint Dislocation; No Code Available; Pain

  MAUDE report 9850481 ↗
• InjuryMar 18, 2020Device Dislodged or Dislocated; Naturally Worn; Device Dislodged or Dislocated; Naturally Worn

  PCF AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS RECURRENT DISLOCATION. PATIENT ALLEGES RECURRENT DISLOCATION, INSTABILITY, SUBLUXATION, PAIN, AND TENDERNESS DURING PALPATION. THE HEAD AND NECK WERE NOTED. THERE WAS DEBRIS UNKNOWN AS TO EXACTLY WHAT THIS WAS. DOI: (B)(6) 2009; DOR: (B)(6) 2010 (RIGHT HIP).

  Patient problems: Discomfort; Joint Dislocation; No Code Available; Pain

  MAUDE report 9847441 ↗
• InjuryMar 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THERE IS NO ALLEGATION REPORTED FROM UNF. AFTER REVIEW OF MEDICAL RECORDS, PATIENT WAS REVISED TO ADDRESS AVASCULAR NECROSIS LEFT HIP. DOI: (B)(6) 2012; DOR: NONE REPORTED (LEFT HIP). PATIENT IS BILATERAL, PLEASE SEE (B)(4) FOR THE RIGHT HIP FIRST REVISION.

  Patient problems: No Code Available

  MAUDE report 9807366 ↗
• InjuryJan 16, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THE PATIENT WAS REVISED TO ADDRESS DISLOCATION AND LOOSENING OF THE DISTAL FEMORAL STEM AT THE BONE TO IMPLANT INTERFACE. ALL FEMORAL COMPONENTS WERE REMOVED AND REPLACED WITH A LARGER RECLAIM STEM. DOI: (B)(6) 2019; DOR: (B)(6) 2020 (RIGHT HIP).

  Patient problems: Joint Dislocation; No Code Available

  MAUDE report 9596711 ↗
• MalfunctionJan 3, 2020Naturally Worn; Naturally Worn

  PPF AND MEDICAL RECORDS RECEIVED. PPF ALLEGES META WEAR AND METALLOSIS. AFTER REVIEW OF MEDICAL RECORDS, THERE IS NO REVISION REPORTED. DOI: (B)(4) 2008. DOR: NONE REPORTED, RIGHT HIP. PLEASE SEE (B)(4) FOR LEFT HIP.

  Patient problems: Foreign Body Reaction

  MAUDE report 9548215 ↗
• InjuryAug 7, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PPF ALLEGES LIMITED MOBILITY. AFTER REVIEW OF MEDICAL RECORDS THE PATIENT WAS REVISED DUE TO INSTABILITY AND RECURRENT DISLOCATION AFTER A FALL. OPERATIVE NOTE STATED, THE HIP APPEARED TO BE IMPINGING ANTERIORLY WITH SOFT TISSUE.

  Patient problems: Fall; Joint Dislocation; Joint Disorder; Limited Mobility Of The Implanted Joint; No Code Available; Tissue Damage

  MAUDE report 8871312 ↗
• InjuryAug 6, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT HAS PAIN AND DISCOMFORT. REMOVING METAL LINER AND METAL HEAD AND GOING BACK IN WITH A CERAMIC HEAD AND POLY LINER. DOI: (B)(6) 2007, DOR: (B)(6) 2019, RIGHT HIP.

  Patient problems: Discomfort; No Code Available; Pain

  MAUDE report 8864253 ↗
• InjuryJun 28, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE CLAIM SUBMISSION FORM AND MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT REVISED TO ADDRESS PAIN. OPERATIVE FINDINGS INCLUDE A LOOSE ACETABULAR CUP AND MEDIAL ACETABULAR WALL LYSIS. DOI: (B)(6) 2008, DOR: (B)(6) 2017, (RIGHT HIP).

  Patient problems: No Code Available; Osteolysis; Pain

  MAUDE report 8745183 ↗
• InjuryMay 21, 2019Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAIN. INTRAOPERATIVELY, THERE WAS FLUID WITHIN THE JOINT, EXTENSIVE AMOUNTS OF FIBRINOUS TISSUE, METAL DEBRIS, OSTEOLYSIS, MILD TO MODERATE AMOUNT OF CORROSION OF THE TAPER AND BEHIND THE METAL LINER. THE CUP WAS NOTED TO BE STABLE. DOI: (B)(6) 2010 - DOR: (B)(6) 2019; (RIGHT HIP).

  Patient problems: Adhesion(s); Edema; No Code Available; Osteolysis; Pain; Test Result

  MAUDE report 8627480 ↗