Profemur PHA01242Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI M684PHA012421), received between Mar 26, 2020 and Feb 7, 2022 — classified as 3 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 7, 2022Loosening of Implant Not Related to Bone-Ingrowth

  ALLEGEDLY, THE NECK AND HEAD WERE REPLACED FOR LEG LENGTH CORRECTION. ADDITIONALLY, RE-SUBSTITUTION OF CUP DUE TO LOOSENING OF ANOTHER COMPANY'S CUP. MPO'S TL SIZE 1 STEM SIDE WAS FINE. (B)(4).

  Patient problems: Unequal Limb Length

  MAUDE report 13472151 ↗
• InjurySep 9, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT COMPLAINED OF PAIN AND VISITED THE CLINIC ON AUG 6TH. THE X-RAY IMAGE SUGGESTED A DISLOCATION AND DISASSOCIATION. DUE TO DISLOCATION/DISASSOCIATION, REVISION THA WAS PERFORMED. STEM WAS NOT REVISED. THE NECK, HEAD AND CUP WERE REVISED. THA IS CARRIED OUT WITH OTHER COMPANIES G7 CUPS. (B)(4). PHYSICIAN'S FINDINGS; ''THE X-RAY SEEMED TO HAVE CLEARLY TURNED OUT, BUT SINCE IT HAD RETURNED TO ITS ORIGINAL STATE, IT WAS SAID THAT IT WAS NOT NECESSARY THIS TIME TO PROPOSE AN ACTUAL PRODUCT SURVEY.''

  Patient problems: Pain

  MAUDE report 12451121 ↗
• InjuryMar 26, 2020Corroded; Corroded

  ALLEGEDLY THE IMPLANTS GENERATE METAL DEBRIS, CORROSION AND METAL IONS, WHICH CAUSE DANGEROUSLY ELEVATED BLOOD LEVELS OF COCR IONS ADVERSE TISSUE REACTIONS, PSEUDOTUMORS, NECROSIS, BONE LOSS .

  Patient problems: No Information

  MAUDE report 9882585 ↗