PROFEMUR® PHAC1224Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI M684PHAC12241), received between Mar 4, 2020 and Apr 10, 2026 — classified as 8 injuries.

The most frequently reported specific device problem is “Break” (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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryApr 10, 2026Break; Noise, Audible

  ALLEGEDLY, ON (B)(6) 2024, THE PATIENT WAS STANDING IN HIS LIVING ROOM AND BENT OVER TO PICK UP A PHONE CHARGER WHEN HE FELT A SUDDEN POP IN HIS RIGHT HIP AND IMMEDIATELY FELL TO THE FLOOR. HE EXPERIENCED PAIN AND WAS UNABLE TO BEAR WEIGHT ON HIS RIGHT LEG. X-RAYS REVEALED AN ANGULATED FRACTURE OF THE FEMORAL COMPONENT OF HIS RIGHT HIP ARTHROPLASTY HARDWARE, LATER CONFIRMED AS A FRACTURED MODULAR NECK STEM, WHICH NECESSITATED REVISION SURGERY PERFORMED ON (B)(6) 2024. NON-REVISED PRODUCTS: PRODUCT ID: DSBFGG58 DYNASTY® BF SHELL 58MM GROUP G/ LOT NO.: 1512229/ QTY: (B)(4). PRODUCT ID: 18080304 CANCELLOUS SELF-TAPPING 6.5MM BONE SCREW 3.5CM LENGTH/ LOT NO.: 1462885/ QTY: (B)(4).

  Patient problems: Pain

  MAUDE report 24841247 ↗
• InjuryFeb 28, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, DISLOCATION/SUBLUXATION. SIDE: L. REVISION NJR: 2865282. GENDER: F. EXPLANTED: FEMORAL STEM.

  Patient problems: Insufficient Information

  MAUDE report 18796275 ↗
• InjuryApr 17, 2023Corroded; Corroded

  ALLEGEDLY, PROFEMUR® TOTAL HIP SYSTEM IMPLANTED IN THE LEFT SIDE HAS FAILED DUE TO CORROSION RELATED METALLOSIS/ADVERSE TISSUE REACTIONS. PATIENT PRESENTED WITH SEVERE PAIN, LACK OF MOBILITY, AND ELEVATED COBALT LEVELS.

  Patient problems: Loss of Range of Motion; Metal Related Pathology; Pain

  MAUDE report 16750891 ↗
• InjuryFeb 27, 2023Break; Break

  ALLEGEDLY, FRACTURE OF A MODULAR NECK (AR VV1 LONG) ON (B)(6) 2023. REVISION SURGERY ON (B)(6) 2023 (AT CLINIC (B)(6), DR. (B)(6)). ADDITIONAL INFORMATION 02/05/2023: ALLEGEDLY, PATIENT SUFFERED A SPONTANEOUS FRACTURE OF THE MODULAR NECK WHILE WALKING. THERE WERE NO PRIOR INDICATIONS OF THIS OCCURRENCE, NO PAIN OR RESTRICTION OF MOVEMENT. SINCE THE BROKEN NECK COULD NOT BE REMOVED DURING THE REOPERATION, THE PROSTHESIS SHAFT HAD TO BE REVISED AND THE FEMUR OPENED. A REVISION HIP STEM WAS USED. THE SURGEON DR. (B)(6) HAS BEEN USING MPO (FORMERLY WRIGHT) MODULARITY FOR ALMOST 30 YEARS AND AFFIRMED THAT HE HAD FOLLOWED ALL SPECIFICATIONS REGARDING IMPLANT "MODULARITY". THE INCIDENT IS REPORTED BY DR. (B)(6) REPORTED TO THE RESPONSIBLE AUTHORITIES (FEDERAL INSTITUTE FOR DRUGS AND MEDICAL DEVICES, BFARM). SINCE THE PATIENT WAS AND IS COMPLIANT, THE IMPLANT FAILURE IS INEXPLICABLE FOR THE PATIENT, AND HE INDICATED TO THE SURGEON THAT LEGAL ACTION SHOULD BE TAKEN AGAINST THE SURGEON AND THE MANUFACTURER. AFTER THE PATIENT'S REHAB, AT THE END OF FEBRUARY, HE ALSO EXPRESSED CONTACT WITH HIS LEGAL COUNSEL. HE ALSO INDICATED THAT HE COULD IMAGINE AN OUT-OF-COURT SETTLEMENT.

  Patient problems: Insufficient Information

  MAUDE report 16443317 ↗
• InjuryNov 7, 2022Adverse Event Without Identified Device or Use Problem

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS REVISION NJR NUMBER: (B)(4). SIDE:R. PRIMARY ASA: P1 - FIT AND HEALTHY.

  Patient problems: Metal Related Pathology

  MAUDE report 15743495 ↗
• InjuryJun 7, 2022Corroded; Corroded

  ALLEGEDLY, ON (B)(6) 2015, PATIENT HAD A RIGHT TOTAL HIP ARTHROPLASTY. PATIENT RECEIVED A PROFEMUR® LONG COBALT CHROME MODULAR NECK (PHAC1224) AND A PROFEMUR® Z FEMORAL STEM MADE OF TITANIUM ALLOY. ON (B)(6) 2020 DUE TO THE FAILURE OF THE DEVICE, PATIENT'S DEVICE WAS SURGICALLY REMOVED BY JAKUB TATKA, M.D., AT NEW YORK PRESBYTERIAN LAWRENCE HOSPITAL IN BRONXVILLE, NY IN A SURGICAL PROCEDURE COMMONLY CALLED A "REVISION." DURING HER REVISION SURGERY, DR. TATKA NOTED "METALLOSIS AND CORROSION CHANGES ON THE TAPER OF THE NECK AND BODY OF THE STEM TAPER" AND EXCISED METALLOSIS AND A PSEUDOTUMOR. DUE TO THE FAILURE OF HER PROFEMUR® TOTAL HIP SYSTEM, DR. TATKA NEEDED TO REMOVE THE WELL-FIXED FEMORAL STEM. PATIENT HAS ALSO SUSTAINED PAIN. THE CUP AND LINER HAVE NOT BEEN INDICATED IN THE REPORT TO BE MICROPORT PRODUCTS . THE CUP, LINER AND HEAD HAVE NOT BEEN INDICATED AS REVISED COMPONENTS.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14621992 ↗
• InjuryFeb 24, 2021Break; Break

  ALLEGEDLY, LEFT NECK BREAKAGE. BASG REF.# (B)(4). ADDITIONAL INFORMATION RECEIVED ON 3/1/2021: INCIDENT DESCRIPTION, PATIENT INFORMATION, ADDITIONAL COMPONENTS ID'S AND LOT NUMBERS, AND IMPLANT AND EXPLANT DATE. ALLEGEDLY, THE PATIENT WALKS ACROSS THE STREET ON (B)(6) 2021 AND REPORTS THAT HE FELL WITHOUT ANY EXTERNAL CAUSE. AFTERWARDS THE LEG NO LONGER RESILIENT.

  Patient problems: Insufficient Information

  MAUDE report 11371637 ↗
• InjuryMar 4, 2020Break; Unstable; Break; Unstable

  ALLEGEDLY, PROFEMUR COCR NECK FRACTURED - RIGHT HIP. MECHANICAL COMPLICATION, PAIN AND INSTABILITY ON THE HIP DUE TO THE BROKEN NECK ARE REPORTED.

  Patient problems: Pain

  MAUDE report 9787957 ↗