PROFEMUR® PHAC1232Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI M684PHAC12321), received between Jan 6, 2020 and Oct 17, 2025 — classified as 14 injuries.

The most frequently reported specific device problem is “Corroded” (10 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 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• InjuryOct 17, 2025Unstable; Unstable

  ALLEGEDLY, PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 AT (B)(6). SHE WAS IMPLANTED WITH THE PROFEMUR® TOTAL HIP SYSTEM, CONSISTING OF A PROFEMUR Z TITANIUM STEM AND A SHORT COBALT-CHROMIUM MODULAR NECK. OVER TIME, THE DEVICE BEGAN TO FAIL AT THE NECK STEM JUNCTION, LEADING TO CORROSION AND THE RELEASE OF METALLIC DEBRIS. THIS CAUSED THE PATIENT TO EXPERIENCE PROGRESSIVE HIP PAIN, PROSTHESIS INSTABILITY, FORMATION OF A PSEUDOTUMOR, AND METALLOSIS (ACCUMULATION OF METALLIC PARTICLES IN THE SURROUNDING TISSUE). ON (B)(6) 2025, THE PATIENT UNDERWENT A REVISION SURGERY AT (B)(6). DURING THIS PROCEDURE, BOTH THE STEM AND THE MODULAR NECK OF THE PROFEMUR® SYSTEM WERE EXPLANTED, DUE TO CORROSION AND RELATED TISSUE DAMAGE. PATHOLOGY CONFIRMED CHRONICALLY INFLAMED FIBROTIC TISSUE WITH ENTRAPPED BONE PARTICLES AND METALLIC DEBRIS, ALONG WITH VISIBLE BLACK CORROSION AT THE NECK STEM JUNCTION, ESTABLISHING THAT THE FAILURE WAS CAUSED BY CORROSION OF THE COBALT-CHROMIUM MODULAR NECK COUPLED WITH THE TITANIUM STEM. PATIENT UNDERWENT A LEFT TOTAL HIP ARTHROPLASTY ON (B)(6) 2017 AT (B)(6). SHE WAS IMPLANTED WITH THE PROFEMUR® TOTAL HIP SYSTEM, CONSISTING OF A PROFEMUR Z TITANIUM

  Patient problems: Metal Related Pathology

  MAUDE report 23325675 ↗
• InjuryOct 23, 2023Corroded; Corroded

  ALLEGEDLY, COCR CORROSION CLAIM (<10). RIGHT.

  Patient problems: Insufficient Information

  MAUDE report 17986778 ↗
• InjuryJul 6, 2022Corroded; Corroded

  ALLEGEDLY, THE PATIENT ON (B)(6) 2020 HAD A LEFT REVISION SURGERY DUE TO CORROSION, ON (B)(6) 2020 THE PATIENT WAS REVISED AGAIN DUE TO INFECTION ON THE SIDE LEFT.

  Patient problems: Unspecified Infection

  MAUDE report 14932519 ↗
• InjuryJul 5, 2022Corroded; Corroded

  ALLEGEDLY, THE PATIENT PRESENTED CORROSION.

  Patient problems: Failure of Implant

  MAUDE report 14916695 ↗
• InjuryJun 8, 2021Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION OF THE OBLONG TAPER OF THE PROFEMUR® COCR MODULAR NECK WHERE IT SEATED IN THE POCKET OF THE PROFEMUR® TITANIUM STEM. (LEFT HIP).

  Patient problems: Insufficient Information

  MAUDE report 11957465 ↗
• InjuryApr 26, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO UNKNOWN REASONS. COMPONENTS NOT REVISED: DYNASTY® A-CLASS® 38MM 15DG GROUP E CROSSLINKED POLY LINER DLXPLE38 LOT: 0501142452. DYNASTY® BF SHELL 54MM GROUP E DSBFGE54 LOT: 1201210358. PROFEMUR® Z FEMORAL STEM S 2 1/3 TP COATED CEMENT LESS PHA00262 LOT: 0901201577. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 2.5CM LENGTH 18080302 LOT: 0111294020.

  Patient problems: Insufficient Information

  MAUDE report 11727698 ↗
• InjuryAug 4, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, WOUND INFECTION IN THE PATIENT RIGHT HIP WAS DETECTED. THE PATIENT HAD A MEDICAL INTERVENTION FOR WOUND DEBRIDEMENT.

  Patient problems: Unspecified Infection

  MAUDE report 10362889 ↗
• InjuryJul 3, 2020Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE NECK-STEM JUNCTION OF HER LEFT HIP.

  Patient problems: No Information

  MAUDE report 10229584 ↗
• InjuryJun 26, 2020Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO COCR CORROSION AT THE NECK-STEM JUNCTION OF HIS RIGHT HIP.

  Patient problems: No Information

  MAUDE report 10200298 ↗
• InjuryJun 26, 2020Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO COCR CORROSION AT THE NECK-STEM JUNCTION OF HIS LEFT HIP.

  Patient problems: No Information

  MAUDE report 10199958 ↗
• InjuryMay 26, 2020Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO COCR CORROSION.

  Patient problems: No Code Available

  MAUDE report 10087321 ↗
• InjuryFeb 26, 2020Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE COCR MODULAR NECK AND TITANIUM STEM, ELEVATED COBALT IONS LEVELS AND LOOSENING OF THE ACETABULAR COMPONENT.

  Patient problems: No Information

  MAUDE report 9758223 ↗
• InjuryJan 6, 2020Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  ALLEGEDLY PATIENT WAS REVISED DUE TO UNKNOWN REASONS. LEFT HIP.

  Patient problems: No Information

  MAUDE report 9555125 ↗
• InjuryJan 6, 2020Material Disintegration; Material Disintegration

  ALLEGEDLY PATIENT WAS REVISED FOR ASEPTIC LOOSENING AND METALLOSIS WAS DISCOVERED INTRAOPERATIVE. RIGHT HIP.

  Patient problems: No Information

  MAUDE report 9554548 ↗