NA 1365-64-000Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 10603295034155), received between Sep 8, 2017 and Apr 9, 2026 — classified as 5 injuries.

The most frequently reported specific device problem is “Degraded” (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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryApr 9, 2026Degraded

  IT WAS REPORTED THAT THE PATIENT HAD A METAL ON METAL HIP DONE IN 2008. METAL ION LEVELS WERE ELEVATED. HEAD HAD CORROSION AT THE HEAD TAPER JOINT. PSEUDOTUMOR PRESENT. LINER AND HEAD WAS REMOVED AND REPLACED WITH A POLY AND TS CERAMIC HEAD. COBALT 44.4 CHROMIUM 6.6 ACTIVITY LEVEL - YES AFFECTED SIDE: LEFT HIP.

  Patient problems: Hypersensitivity/Allergic reaction; Metal Related Pathology

  MAUDE report 24832832 ↗
• InjuryJun 29, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  MEDICAL RECORDS RECEIVED. AFTER REVIEW OF MEDICAL RECORDS, IT WAS REPORTED THAT THE PATIENT FELL SUSTAINING THE AFOREMENTIONED PERIPROSTHETIC HIP FRACTURE. PATIENT ALSO HAD 3 PREVIOUS DISLOCATION EVENT. THE PATIENT WAS THEN REVISED FOR RIGHT PERIPROSTHETIC PROXIMAL FEMUR FRACTURE AND METAL ON METAL THA COMPONENTS WITH EXTENSIVE METALLOSIS AND SOFT TISSUE NECROSIS. OPERATIVE NOTES INDICATE THAT A EXTENSIVE HEMATOMA WAS ENCOUNTER. IT WAS NOTED THAT NO FASCIA PRESENT AS THERE WAS A DIRECT LINE FROM THE HEMATOMA INTO THE JOINT HIP. IT APPEARED THAT THERE WAS EXTENSIVE METALLOSIS AND SOFT TISSUE NECROSIS LIKELY RELATED TO THE METAL ON METAL ARTICULATION. THE POSTERIOR ASPECT OF THE GREATER TROCHANTER WAS NOTED TO BE DENUDED OF THE SOFT TISSUE ATTACHMENT. IT WAS INDICATED THAT STEM WAS STABLE AND ONLY THE GREATER TROCHANTER WAS FRACTURED AND FRAGMENTED. THERE WAS NOTED TO BE SOME METALLOSIS ALONG THE TRUNNION. DOI: (B)(6) 2007. DOR: (B)(6) 2021. RIGHT HIP.

  Patient problems: Fall; Foreign Body Reaction; Hematoma; Joint Dislocation; Unspecified Tissue Injury

  MAUDE report 12088992 ↗
• InjuryMar 18, 2020Naturally Worn; Naturally Worn

  AFTER REVIEW OF MEDICAL RECORDS PATIENT WAS REVISED TO ADDRESSED FAILED LEFT TOTAL HIP ARTHROPLASTY, METAL ON METAL TOTAL HIP REPLACEMENT WITH TRUNNIONS, CORROSION AND ASEPTIC GROSS LOOSENING OF THE FEMORAL COMPONENT. OPERATIVE NOTES INDICATED PAIN, POSSIBLE METALLOSIS, TRUNNIONS CAUSING LOOSENING. THERE WAS NO BLACK DEBRIS SEEN BUT THERE WAS BROWN CORROSION DEBRIS SEEN WITHIN THE JOINT SPACE. THERE WAS DEFINITE WEAR ON THE TRUNNION AND CORROSION EVIDENT. INSPECTING THE FEMORAL IMPLANT, IT WAS GROSSLY LOOSE. DOI: (B)(6) 2010. DOR: (B)(6) 2019; LEFT HIP.

  Patient problems: Foreign Body Reaction; Limited Mobility Of The Implanted Joint; No Code Available; Pain

  MAUDE report 9849966 ↗
• InjuryApr 16, 2019Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PINNACLE PPF AND STICKER SHEETS RECEIVED. PPF ALLEGES PULMONARY EMBOLISM. DOI: (B)(6) 2007 - DOR: NONE REPORTED, (RIGHT HIP).

  Patient problems: Pulmonary Embolism

  MAUDE report 8517812 ↗
• InjurySep 8, 2017Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available; Adverse Event Without Identified Device or Use Problem; Appropriate Device Problem Term/Code Not Available

  AUG 9, 2017: LEGAL MEDICAL RECORDS RECEIVED. PFS ALLEGES MUSCLE SPASMS, PAIN, DISCOMFORT, LOSS OF MOBILITY, AND HIP LOOSENING AND POPPING OUT OF PLACE. AFTER REVIEW OF THE MEDICAL RECORDS FOR THE MDR REPORTABILITY, CLINICAL NOTES REPORTED OF SOME OCCASIONAL PAIN AFTER LONG WALKING, SENSE OF SUBLUXATION, CRAMPING SENSATION, FRANK INSTABILITY AND SOME SLIGHT CREPITUS. THERE IS NO REPORT OF REVISION AT THIS TIME. LABORATORY RESULTS FOR CHROMIUM WAS BELOW 7PPB. PRODUCT INFORMATION PROVIDED. ADDING AN UNKNOWN DEPUY HIP COMPONENT FOR THE ALLEGED LOOSENING.

  Patient problems: Discomfort; Joint Dislocation; Limited Mobility Of The Implanted Joint; Pain

  MAUDE report 6851228 ↗