Profemur PHA01222Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684PHA012221), received between Aug 30, 2021 and Jan 26, 2022 — classified as 6 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryJan 26, 2022Corroded; Corroded

  ALLEGEDLY, PATIENT STARTED TO EXPERIENCE PAIN IN OR AROUND HIS RIGHT HIP JOINT, ALONG WITH COBALT AND CHROMIUM LEVELS THAT WERE INCREASING OVER THE PAST FEW YEARS. CONTINUING AND INCREASING PAIN IN HIS RIGHT HIP, AND ELEVATED SERUM COBALT/CHROMIUM LEVELS REPORTED ON (B)(6) 2019. IN THE (B)(6) 2019, RIGHT HIP REVISION PROCEDURE PATIENT´S RIGHT HIP WAS REVISED, RESULTING IN REMOVAL AND REPLACEMENT OF THE PREVIOUSLY IMPLANTED CONSERVE-DYNASTY-PROFEMUR HIP SYSTEM METAL-ON-METAL BEARING SURFACE WITH A BIOMET DUAL MOBILITY ACTIVE ARTICULATION HIP SYSTEM, AND A MICROPORT ALUMINA MATRIC COMPOSITE DELTA OPTION HEAD, AND A DELTA OPTION NECK SLEEVE. AN OPERATIVE NOTE FROM THE (B)(6) 2019, REVISION PROCEDURE REFERENCES A FINDING OF STAINED SYNOVIUM AND SIGNIFICANT CORROSION ON THE MODULAR NECK. THE EXTRACTED MODULAR NECK SHOWS SIGNIFICANT CORROSION ON BOTH THE PROXIMAL AND DISTAL TRUNNIONS OF THAT DEVICE. DUE TO CONCERNS WITH A HISTORY OF THE WRIGHT MEDICAL TITANIUM PROFEMUR MODULAR NECKS CORRODING, AND FRACTURING, THE INTRA-OPERATIVE MEDICAL DECISION WAS ALSO MADE BY SURGEON TO REMOVE AND REPLACE THE TITANIUM PROFEMUR MODULAR NECK OF THAT HIP WITH A NEW, NOT YET CORRODING, TITANIUM MODULAR NE

  Patient problems: Metal Related Pathology

  MAUDE report 13358105 ↗
• InjurySep 15, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS HOSPITALIZED BECAUSE HE FELL AND DISLOCATED AT THE FACILITY. PHYSICIAN'S FINDINGS: (B)(6) 2021 CONFIRMED IN THE OPERATION, HE WAS CONTRACTED TO THE EXTENT THAT HE COULD NOT BE REDUCED, AND HE MAY HAVE BEEN ABSENT FROM G26 EARLIER. (B)(4).

  Patient problems: Fall

  MAUDE report 12477770 ↗
• InjurySep 3, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION. COMPONENTS NOT REVISED: PRODUCT NAME: PROFEMUR® R GRIT BLASTED PROX BODY SMALL PART ID: PPW39102. PRODUCT NAME: PROFEMUR® ROUGHENED DISTAL STEM, TAPERED PART ID: PPW38046.

  Patient problems: Insufficient Information

  MAUDE report 12422021 ↗
• InjuryAug 31, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR CUP LOOSENING AND DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12402321 ↗
• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Insufficient Information

  MAUDE report 12388554 ↗
• InjuryAug 30, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED ON 02,SEP, 2021. ALLEGEDLY, A PATIENT WAS REVISED FOR DISLOCATION.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 12385807 ↗