PROFEMUR® PHAC1222Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI M684PHAC12221), received between Jul 29, 2020 and Jan 30, 2023 — classified as 6 injuries.

The most frequently reported specific device problem is “Corroded” (4 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 30, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Metal Related Pathology

  MAUDE report 16263283 ↗
• InjuryApr 25, 2022Corroded; Corroded

  ALLEGEDLY, PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP DUE TO CORROSION AT THE NECK-STEM JUNCTION, PAIN AND ELEVATED COBALT AND CHROMIUM LEVELS. DR. PENENBERG REMOVED AND REPLACED THE WRIGHT PROFEMUR COCR MODULAR NECK, WRIGHT ACETABULAR HEAD, AND POLYETHYLENE LINER OF PLAINTIFF'S ARTIFICIAL HIP. PRODUCTS NOT REVISED: PART ID: PHA00242 PROFEMUR® Z FEMORAL STEM S 6 CEMENT LESS/ LOT NUMBER: 0511353146/ QTY:1

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14197247 ↗
• InjuryApr 6, 2022Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, THE PATIENT HAD METAL-ON-METAL HIP ARTHROPLASTY THAT HAS BEEN PAINFUL FOR 4 YEARS. AFTER REVIEWING HIS RADIOGRAPHS AND OPERATIVE REPORT THE CHROMIC COBALT LEVELS WERE ALL SIGNIFICANTLY ELEVATED. THERE WAS MILD EVIDENCE OF CORROSION AT THE TRUNNION OF THE BASE OF THE MODULAR NECK HOWEVER IT WAS VERY MINIMAL AND ON THE INSIDE OF THE FEMORAL COMPONENT IT WAS ALMOST COMPLETELY ABSENT. THE FEMORAL COMPONENTS HAD METALLIC DEBRIS.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14028822 ↗
• InjuryApr 20, 2021Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION ON COCR MODULAR NECK.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 11697867 ↗
• InjuryNov 18, 2020Corroded; Corroded

  ALLEGEDLY, PATIENT WAS REVISED DUE TO CORROSION AT THE NECK-STEM JUNCTION. RIGHT HIP COMPONENTS NOT REVISED: DYNASTY® PC SHELL 54MM GROUP E DSPCGE54 1400657. DYNASTY® A-CLASS® 38MM 15DG GROUP E CROSSLINKED PO PRODUCT NUMBER: DLXPLE38 LOT BATCH: 0201067755. CONSERVE® TOTAL MEDIUM NECK SLEEVE PRODUCT NUMBER: 38NS0000, LOT BATCH: 0711384693. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 4.0CM LEN PRODUCT NUMBER: 18080305, LOT BATCH: 0501143695. CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.0CM LEN PRODUCT NUMBER: 18080303, LOT BATCH: 075239810. LEGAL FILE RECEIVED ON 11/11/2020 FROM DEBBY DAURER: NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Information

  MAUDE report 10860306 ↗
• InjuryJul 29, 2020Appropriate Device Problem Term/Code Not Available

  ALLEGEDLY, PATIENT'S WOUND IS STILL DRAINING AND GROIN PAIN IN HIS RIGHT HIP. HEAD, NECK, LINER AND DUAL MOBILITY WERE SWAPPED OUT FOR A NEW ONES. PREVIOUS REVISION CAPTURED UNDER THE INCIDENT GROUP: (B)(4).

  Patient problems: Fluid Discharge; Pain

  MAUDE report 10339519 ↗