Profemur PHA00268Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI M684PHA002681), received between Dec 18, 2019 and Jul 26, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Difficult to Remove” (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 16, 2026.

Most reported problems

Recent adverse event reports

The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 26, 2022Difficult to Remove; Difficult to Remove

  ALLEGEDLY PT. NOW HAS ELEVATED METAL IONS. ORIGINALLY PART OF IDE / CERAMIC ON METAL ARTICULATION SYSTEM CLINICAL STUDY BUT NOT ANY LONGER. ADDITIONAL INFORMATION RECEIVED ON APRIL 19, 2022: PATIENT DEVELOPED ADVERSE SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PROGRESSIVELY WORSENING PAIN IN AND AROUND HIS RIGHT HIP JOINT, AS WELL AS NEUROLOGIC SYMPTOMS INCLUDING PERIPHERAL NEUROPATHY, TINNITUS, SOME BALANCE/COORDINATION ISSUES, A HEAL FRACTURE AS A DIRECT RESULT OF THOSE BALANCE/COORDINATION ISSUES, AND B12 DEFICIENCY. LABORATORY TEST RESULTS REPORTED ON (B)(6) 2020, REVEALED ELEVATED SERUM CHROMIUM AND BLOOD COBALT LEVELS IN PATIENT. ON (B)(6) 2021, PATIENT HAD A REVISION SURGERY PERFORMED ON HIS RIGHT HIP BY (B)(6), M.D., AT (B)(6) CLINIC (B)(6) HOSPITAL, (B)(6). EARLY IN HIS (B)(6) 2021, OPERATIVE REPORT, DR. (B)(6) NOTED, "METALLOSIS DEBRIS AT THE EXTERNAL ROTATORS." AFTER REMOVAL OF THE CONSERVE® FEMORAL HEAD FROM THE PROFEMUR® PLUS MODULAR NECK, DR. (B)(6) NOTED "A FAIR AMOUNT OF BLACK CORROSION DISCOLORATION AT THE TAPER ON BOTH COMPONENTS." IN THE (B)(6) 2021, REVISION SURGERY, DR. (B)(6), REMOVED THE WRIGHT MEDICAL PROFEMUR® HIP SYSTEM, INCLUDING THE PROFEMUR® PLUS COCR MODUL

  Patient problems: Balance Problems; Bone Fracture(s); Metal Related Pathology; Neuropathy; Pain; Tinnitus; Vitamin Deficiency

  MAUDE report 15105288 ↗
• InjuryDec 18, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, INFECTED ALL IMPLANTS WILL BE PULLED.

  Patient problems: Unspecified Infection

  MAUDE report 9491164 ↗