NA 1365-65-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 10603295034193), received between Jul 25, 2017 and Aug 11, 2021 — classified as 7 injuries.

The most frequently reported specific device problem is “Corroded” (1 report).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryAug 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PFS AND MEDICAL RECORDS RECEIVED. REVISION OPERATIVE NOTES INDICATE THAT THE PATIENT WAS REVISED DUE TO "CHRONIC DISLOCATION EFFECTS IN THE FACE OF POLY LINER DISLODGEMENT." AD 12 JUL 2021: IN ADDITION TO WHAT WAS PREVIOUSLY ALLEGED, PFS ALLEGES ELEVATED METAL IONS. AFTER REVIEW OF MEDICAL RECORDS, NO NEW ALLEGATION WAS REPORTED. DOI: (B)(6) 2010, DOR: (B)(6) 2012, RIGHT HIP.

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

  MAUDE report 12309775 ↗
• InjuryMar 12, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AFTER REVIEW OF MEDICAL RECORDS, THE PATIENT WAS REVISED TO ADDRESS PAINFUL ASEPTIC FAILURE OF THE PATIENT'S RIGHT TOTAL HIP ARTHROPLASTY. THERE WAS PRESENCE OF THICK, FIBROTIC, REACTIVE TISSUE, FLUID WITHIN THE JOINT, PERIARTICULAR EROSIONS AND STRESS SHIELDING BEHIND THE SHELL. DOI: (B)(6) 2010 - DOR: (B)(6) 2017 (RIGHT HIP).

  Patient problems: Adhesion(s); Edema; Local Reaction; No Code Available; Pain; Pocket Erosion

  MAUDE report 9825845 ↗
• InjuryMar 4, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PPF AND IMPLANT RECORDS RECEIVED. PPF ALLEGES PSEUDOTUMOR. DOI: (B)(6) 2010 - DOR: (B)(6) 2017 (LEFT HIP).

  Patient problems: No Code Available; Tissue Damage

  MAUDE report 8386161 ↗
• InjuryJan 22, 2019Material Disintegration; Material Disintegration

  PPF ALLEGES PSEUDOTUMOR, METAL WEAR AND METALLOSIS AND ELEVATED METAL IONS.

  Patient problems: No Code Available; Test Result; Tissue Damage

  MAUDE report 8266733 ↗
• InjuryNov 29, 2018Appropriate Device Problem Term/Code Not Available; Appropriate Device Problem Term/Code Not Available

  PINNACLE LITIGATION RECORD RECEIVED. LITIGATION ALLEGES INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8117295 ↗
• InjuryFeb 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGES ELEVATED CHROMIUM AND COBALT LEVELS IN BLOOD AND MRI RESULTS SHOWED NECROSIS AT THE LEFT HIP JOINT. IT WAS ALSO ALLEGED THAT THERE WAS LOOSE HIP, PAIN, METALLOSIS, DISCOMFORT, INJURIES, REDUCED MOBILITY, AND EMOTIONAL DISTRESS. AFTER REVIEW OF MEDICAL RECORDS FOR MDR REPORTABILITY, PATIENT WAS REVISED TO ADDRESS FAILED LEFT METAL ON METAL TOTAL METALLOSIS AND OBESITY. OPERATIVE NOTES REPORTED OF SIGNIFICANT METALLOSIS, PSEUDOCAPSULAR FORMATION, SIGNIFICANT TRUNNIONOSIS/ CORROSION, BLACKENING OF THE TRUNNION, AND EXTENSIVE BLACK CORROSIVE APPEARING MATERIAL BEHIND THE METAL LINER. LABORATORY RESULT FOR METAL IONS WERE BELOW 7. CHROMIUM: 1.6 PBB. COBALT: 3.2 PBB. DOI: (B)(6) 2009; DOR: (B)(6) 2015; LEFT HIP (PINNACLE).

  Patient problems: Discomfort; Distress; Necrosis; Pain; Tissue Damage

  MAUDE report 7281814 ↗
• InjuryJul 25, 2017Corroded; Metal Shedding Debris; Naturally Worn; Appropriate Device Problem Term/Code Not Available; Corroded; Metal Shedding Debris; Naturally Worn; Appropriate Device Problem Term/Code Not Available

  JUN 27, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES PAIN, LACK OF MOBILITY AND LEG DISCREPANCY THAT RESULTED TO ROTOSCOLIOSIS, AND LOWER BACK PAIN. AFTER REVIEW OF THE MEDICAL RECORDS FOR MDR REPORTABILITY, IT WAS STATED THAT THE PATIENT WAS REVISED TO ADDRESS TRUNNIONOSIS WITH METAL DEBRIS. PATIENT WAS NOTED TO HAVE SIGNIFICANTLY ELEVATE METAL IONS. REVISION NOTE STATED THAT THERE WAS A SIGNIFICANT SCARRING BETWEEN ILIOTIBIAL BAND AND VASTUS LATERALIS, FLUID FROM THE HIP, CHRONIC GRANULOMATOUS TISSUE NOTICED IN THE PERICAPSULAR TISSUE. IT WAS ALSO STATED THAT THERE WAS A METAL WEAR AND DAMAGE TO THE SUPERIOR HALF OF THE FEMORAL TAPER CONSISTENT WITH GALVANIC AND CREVICE CORROSION AND DAMAGE TO THE TAPER ON THE FEMORAL HEAD. CLINIC NOTES INDICATE SOME EDEMA AROUND THE LEFT HIP. THERE ARE NO LAB VALUES PROVIDED FOR THE REPORTED ELEVATED METAL IONS. THIS COMPLAINT WAS UPDATED ON: JUL 10, 2017.

  Patient problems: Foreign Body Reaction; Irritation; Loss of Range of Motion; Pain

  MAUDE report 6739592 ↗