PROFEMUR® PHAC1252Recalls & reported problems

Summary

The FDA's MAUDE database contains 37 adverse event reports that list this exact device (DI M684PHAC12521), received between May 9, 2019 and Feb 11, 2026 — classified as 37 injuries.

The most frequently reported specific device problem is “Corroded” (25 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 25 most recent of 37 reports, in the reporter's own words as published by the FDA.

• InjuryFeb 11, 2026Break

  ALLEGEDLY, REVISION SURGERY SCHEDULED FOR (B)(6) 2026. REP RECEIVED X-RAY ON (B)(6) 2026 SHOWING A BROKEN NECK. OSTEOMETY REQUIRED. WHILE IN SURGERY REQUESTED LINERS, WE DIDN'T HAVE, SO EVERYTHING WAS REVISED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24317709 ↗
• InjuryMar 7, 2025Corroded; Corroded

  ALLEGEDLY, DOCTOR RECOMMENDED THE REVISION SURGERY AFTER PLAINTIFF PRESENTED WITH PROGRESSIVE RIGHT HIP PAIN, ELEVATED ION LEVELS, METALLOSIS CHANGES AROUND THE FEMORAL NECK AND SURROUNDING SOFT TISSUES AROUND THE PROXIMAL FEMUR, ADVERSE LOCAL TISSUE REACTION AND LACK OF MOBILITY. THE REVISION WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE. PRODUCTS NOT SPECIFIED THEY WERE REVISED: PRODUCT ID: DBFPGD52 DYNASTY® BF SHELL PRIMARY 52MM GROUP D, LOT: 1684715, QTY:1.

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

  MAUDE report 21547324 ↗
• InjuryFeb 5, 2025Corroded; Corroded

  ALLEGEDLY, ON (B)(6) 2023 THE PATIENT VISITED A DOCTOR BECAUSE SHE WAS HAVING PAIN. AT THAT TIME SHE WAS DIAGNOSED WITH A GLUTEUS MEDIUS TENDON TEAR. ON (B)(6) 2023, THE DOCTOR INFORMED HER THAT THE CHROMIUM LEVEL IS 0.8, AND HER COBALT LEVEL IS 2.7, ABOVE 1 PPB THRESHOLD. THE DOCTOR INFORMED HER THAT AT THIS POINT IN TIME, THEY WILL WAIT FOR HER TITANIUM LEVEL TO COME BACK. IF HER TITANIUM LEVEL IS ABOVE 10, THIS WOULD BE CONCERNING FOR MECHANICALLY ASSISTED CREVICE CORROSION AT THE NECK-STEM TAPER JUNCTION. OVER THE NEXT YEAR IT WAS DETERMINED THAT HER COBALT AND CHROMIUM LEVELS WERE NOT STABLE. DURING THE REVISION SURGERY THE DOCTOR FOUND: FAILED RIGHT TOTAL HIP ARTHROPLASTY; RIGHT HIP, ABDUCTOR TEAR AND METAL DEBRIS WAS NOTED AT THE STEM-NECK JUNCTION. NON MPO PRODUCTS: PRODUCT ID: 6230040E X3? LINERS/ LOT NO.: MICRVN9/ QTY: 1. PRODUCT ID: 5000354E X3? STRYKER TRIDENT ACETABULAR SYSTEM/ LOT NO.: NI/ QTY: 1.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 21313992 ↗
• InjuryOct 3, 2024Corroded; Corroded

  ALLEGEDLY, PATIENT UNDERWENT REVISION SURGERY ON RIGHT HIP DUE TO PAIN FROM UNDERLYING MECHANICAL ASSISTED CREVICE CORROSION FROM MODULAR, COBALT CHROME RIGHT HIP REPLACEMENT WITH AN ELEVATED COBALT LEVELS AND EVIDENCE OF PSEUDOTUMOR ON MRI AND METALLOSIS. NON MPO PRODUCTS: ZIMMER BIOMET RB 50 MM ACETABULAR COMPONENT, 50/36 POLYLINER, 25 MM ACETABULAR SCREW.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 20360565 ↗
• InjuryJun 18, 2024Corroded; Corroded

  ALLEGEDLY, PATIENT UNDERWENT A LEFT-SIDED TOTAL HIP ARTHROPLASTY ON (B)(6) 2020. ON OR ABOUT (B)(6) 2024, THE PATIENT REPORTED TO THE SURGEON PAIN, DEBILITATING LACK OF MOBILITY, AND HE RECOMMEND REVISION SURGERY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. THE MODULAR NECK SLOT AND FEMORAL NECK DISTAL END HAS CORROSIVE CHANGES AND METAL DEBRIS CONSISTENT WITH COCR DAMAGE. NON REVISED PRODUCTS: PRODUCT ID: P2LXSD36 PRIME A-CLASS® XLPE STANDARD / LOT NO.: 1835920 / QTY: 1. PRODUCT ID: P3SBQD54 PRIME BIOFOAM QUAD SHELL / LOT NO.: 1834699 / QTY: 1.

  Patient problems: Insufficient Information

  MAUDE report 19559348 ↗
• InjuryApr 29, 2024Break; Corroded; Break; Corroded

  ALLEGEDLY, REVISION SURGERY WAS NECESSARY BECAUSE THE DEVICE FAILED DUE TO CORROSION AT THE HEAD-NECK JUNCTION AND NECK-STEM JUNCTION. THE PATIENT EXPERIENCE FRACTURE AT THE STEM AND MODULAR NECK JUNCTION, METALLOSIS, TISSUE REACTION, PSEUDOTUMOR, PAIN, LOSS OF MOBILITY AND CORROSION.

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

  MAUDE report 19202538 ↗
• InjuryFeb 1, 2024Break; Noise, Audible; Break; Noise, Audible

  ALLEGEDLY, PATIENT WAS WALKING AND FELT A POP IN HIS RIGHT HIP, WENT TO THE EMERGENCY ROOM, WHERE HE WAS NOTED TO HAVE A FRACTURE OF HIS MODULAR NECK PROSTHESIS.

  Patient problems: Insufficient Information

  MAUDE report 18625564 ↗
• InjuryNov 7, 2023Corroded; Corroded

  ALLEGEDLY, PAIN AROUND THE LEFT HIP JOINT. LABORATORY TEST RESULT OBTAINED ON (B)(6) 2022 INDICATE ELEVATED BLOOD COBALT LEVELS. THE IMPLANTS WERE CORRODED AT THE NECK-STEM JUNCTION. NON-MPO PRODUCTS: ZIMMER BIOMET PIN STEINMAN THREAD 3/16IN LOT: 62404689.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 18085563 ↗
• InjuryOct 18, 2023Corroded; Corroded

  ALLEGEDLY, COCR CORROSION CLAIM (<10) LEFT. PATIENT HAS BILATERAL HIPS. PRODUCTS ASSOCIATED WITH WHICH HIP IS UNKNOWN. CONTRALATERAL HIP IS CAPTURED IN INCIDENT GROUP (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17961484 ↗
• InjuryOct 18, 2023Corroded; Corroded

  ALLEGEDLY, COCR CORROSION CLAIM (+10) RIGHT. PATIENT HAS BILATERAL HIPS. PRODUCTS ASSOCIATED WITH WHICH HIP IS UNKNOWN. CONTRALATERAL HIP IS CAPTURED IN INCIDENT GROUP (B)(4).

  Patient problems: Insufficient Information

  MAUDE report 17961454 ↗
• InjurySep 18, 2023Corroded; Corroded

  ALLEGEDLY, PATIENT HAD PROGRESSIVE RIGHT HIP PAIN, DEVICE FAILED DUE TO CORROSION AT THE NECK-STEM JUNCTION. REVISION COULD NOT BE CONFIRMED: PART ID: DBFPGB48 DYNASTY® BF SHELL PRIMARY, LOT: 1581163, QTY: 1.

  Patient problems: Pain

  MAUDE report 17765605 ↗
• InjuryJun 2, 2023Corroded; Corroded

  ALLEGEDLY, 80% TEAR OF GLUTEUS MEDIUS WITH FIBERS REMAINING OVER ANTERIOR EDGE OF GREATER TROCHANTER, BALD REMAINDER OF GREATER TROCHANTER. TRUNNIOSIS WITH BURNISHING OF THE FEMORAL SHORT NECK TRUNNION AT BOTH THE HEAD AND PROXIMAL BODY INTERFACES. STABLE ACETABULAR, FEMORAL COMPONENTS. YELLOW CLEAR SEROUS JOINT FLUID, SENT FOR CELL COUNT, CULTURE. PSEUDOTUMOR OVER GREATER TROCHANTER SENT TO PATHOLOGY. PAIN, CORROSION AND SUSPECTED METALLOSIS. NON REVISED PRODUCTS: PRODUCT ID: SPHS8000 PROFEMUR® R 135MM.STEM SIZE 10 MTS.FINISH STRAIGHT/TAPER/ LOT NO.: 07493194/ QTY: 1.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17049505 ↗
• InjuryJun 1, 2023Material Frayed; Material Frayed

  ALLEGEDLY, THE PATIENT HAS PAIN, AND HAS BEEN REVISED FROM THE COCR NECK TO THE TI NECK. PATIENT STATED HAD FRETTING, BUT HER COCR LEVELS WERE NOT TOO ELEVATED BASED ON WHAT THE DOCTOR TOLD. PRODUCTS NOT REVISED: DSPCGB48 PRODUCT ID: DYNASTY PC SHELL LOT# 1417042 QTY: 1, DLXPGB28 PRODUCT ID: DYNASTY POLY LINER LOT# 1567743 QTY: 1, PLS0R413 PRODUCT ID: PROFEMUR RENAISSANCE STEM LOT# 1550698 QTY: 1.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 17043386 ↗
• InjuryNov 25, 2022Corroded; Naturally Worn; Corroded; Naturally Worn

  ALLEGEDLY, ON (B)(6) 2017, PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY. PATIENT RECEIVED THE PROFEMUR SHORT COBALT CHROME MODULAR NECK (PHAC1252) AND A PROFEMUR RENAISSANCE FEMORAL STEM MADE OF TITANIUM ALLOY. PATIENT NOW EXPERIENCES ON-GOING PAIN AND HAS BEEN TOLD HE IS IN NEED OF REVISION SURGERY DUE TO "METAL-ON-METAL WEAR" AND THAT HIS COBALT AND CHROMIUM LEVELS ARE ELEVATED. DUE TO FAILURE OF HIS DEVICE, PATIENT IS IN THE PROCESS OF SCHEDULING A REVISION SURGERY TO REMOVE THE DEFECTIVE DEVICE. IT HAS BEEN STATED ALSO THAT THE PROFEMUR TOTAL HIP SYSTEM IMPLANTED ON PATIENT'S LEFT SIDE HAS SUBSEQUENTLY FAILED DUE TO CORROSION OF THE MODULAR NECK. THE DATE OF THE REVISION SURGERY HAS NOT BEEN INDICATED AND IT HAS NOT BEEN CONFIRMED THAT THE REVISION SURGERY HAS ALREADY BEEN PERFORMED.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 15864702 ↗
• InjuryJun 27, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT'S HIP WAS LOCKING UP. QUALITY SYSTEMS DIRECTOR RECEIVED A CALL FROM PATIENT ON (B)(6) 2022 WHERE PATIENT WANTED A REVISION SURGERY COVERED BY MICROPORT ORTHOPEDICS. PATIENT HAS ALSO A FRIEND WANTING TO ASK FOR THE SAME THING TOO. PATIENT'S FRIEND CASE IS CAPTURED UNDER INCIDENT NUMBER (B)(4). IT HAS NOT BEEN INDICATED IF THE REVISION SURGERY HAS HAPPENED YET. REASONS FOR REVISION SURGERY ARE ALSO UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 14836135 ↗
• InjuryMay 23, 2022Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT UNDERWENT INDEX SURGERY ON (B)(6) 2015. HOWEVER, PATIENT HAD PAIN AND RECURRENT INSTABILITY AND UNDERWENT REVISION SURGERY ON (B)(6) 2017. THE CUP, SCREWS, LINER, HEAD AND NECK WERE REVISED. THE STEM PHA00606, STEM REVISION "PROFEMUR® Z", LOT: 068501170 WAS NOT REVISED. THIS REVISION SURGERY HAS BEEN CAPTURED UNDER MICROPORT INCIDENT GROUP (B)(4). DURING REVISION SURGERY, PATIENT WAS IMPLANTED WITH A PHAC1252 PROFEMUR® NECK VAR/VAL 8DG SHORT COBALT CHROME AND A 26000020 COCR TRANSCEND® FEMORAL HEAD 28MM SLT TAPER X-LONG FROM WRIGHT MEDICAL. PATIENT RECEIVED ALSO A LINER, INSERT AND ACETABULAR SHELL FROM STRYKER MEDICAL. SINCE HER REVISION ON (B)(6) 2017, PATIENT HAS BEEN COMPLAINING OF ISSUES BUT HAS NOT YET INDICATED WHAT THOSE ISSUES ARE. PATIENT WAS TOLD SHE NEEDED ANOTHER REVISION HOWEVER IT HAS NOT BEEN INDICATED IF IT HAS HAPPENED YET. CHROMIUM LEVEL IS CURRENT 0.2.

  Patient problems: Pain

  MAUDE report 14472219 ↗
• InjuryMay 12, 2022Corroded; Corroded

  ALLEGEDLY, THE PATIENT HAD CORROSION OF THE PROFEMUR® PLUS COCR MODULAR NECK WHERE IT IS JOINED TO THE PROFEMUR® PLASMA Z FEMORAL STEM ADDITIONAL THE PATIENT IS NOW SCHEDULED TO HAVE HIS RIGHT HIP REVISED ON (B)(6) 2022, BY DR. IN (B)(6) 2021 PLAINTIFF DEVELOPED ADVERSE SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PROGRESSIVELY WORSENING PAIN IN AND AROUND HIS HIP JOINTS. IN (B)(6) OF 2021 AN MRI DEMONSTRATED LARGE FLUID FILLED COLLECTIONS OVER BOTH OF PLAINTIFF'S HIPS. IN (B)(6) OF 2021 LABORATORY TESTS ALSO REVEALED THAT PLAINTIFFS COBALT AND CHROMIUM LEVELS IN HIS BLOOD WERE SIGNIFICANTLY ELEVATED.

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

  MAUDE report 14375135 ↗
• InjuryApr 20, 2022Break; Naturally Worn; Break; Naturally Worn

  ALLEGEDLY, THERE WAS A FRACTURE OF THE FEMORAL NECK ON (B)(6)2022. PX HAD REVISION SURGERY. INTRAOPERATIVE FINDINGS INCLUDED FAILURE OF THE NECK SHAFT JUNCTION OF THE PROSTHESIS WITH RESULTANT METALLOSIS AND WEAR OF SURROUNDING SOFT TISSUE. NO REVISED: DSPCGF56 DYNASTY® PC SHELL 56MM GROUP F LOT# 1549941.

  Patient problems: Metal Related Pathology; Pain

  MAUDE report 14160354 ↗
• InjuryJan 31, 2022Corroded; Insufficient Device Problem Information; Corroded; Insufficient Device Problem Information

  ALLEGEDLY, COMPONENTS REVISED FOR UNKNOWN REASONS. HIGH BMI.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available; Loss of Range of Motion; Pain

  MAUDE report 13397051 ↗
• InjuryAug 12, 2021Malposition of Device; Malposition of Device

  ALLEGEDLY, THE PATIENT PRESENTED HIMSELF DURING THE CONSULTATION. DURING THE X-RAY DIAGNOSTICS, IT WAS NOTICED THAT THE ABOVE ADAPTER IS TILTED. IN CONSULTATION WITH THE MANUFACTURER, IT WAS DECIDED THAT THE PROSTHESIS MUST BE CHANGED IN THE EVENT OF V.A. PROSTHESIS FAILURE. BFARM CASE NUMBER: (B)(4). ADDITIONAL INFORMATION RECEIVED ON 07/23/2021: DATE OF ORIGINAL AND REVISION SURGERY ADDED.

  Patient problems: Insufficient Information

  MAUDE report 12314326 ↗
• InjuryJun 8, 2021Corroded; Corroded

  ALLEGEDLY, PATIENT 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. (RIGHT HIP).

  Patient problems: Failure of Implant

  MAUDE report 11957092 ↗
• InjuryMay 5, 2021Corroded; Material Disintegration; Corroded; Material Disintegration

  ALLEGEDLY, THE PATIENT WAS REVISED CORROSION AT THE NECK-STEM JUNCTION, ADVERSE LOCAL TISSUE REACTION AND METAL DEBRIS.

  Patient problems: Metal Related Pathology

  MAUDE report 11779640 ↗
• InjuryMar 29, 2021Corroded; Corroded

  ALLEGEDLY, ON OR ABOUT (B)(6) 2020 IT WAS DISCOVERED THAT THE DEVICE FAILED DUE TO METAL DEBRIS, CORROSION AND RESULTANT METAL IONS, DUE TO THE METAL ON METAL DESIGN BETWEEN THE ARTICULATING SURFACES. THIS PATIENT HAD METAL ON POLYETHYLENE ARTICULATING COMPONENTS. IT IS ALSO ALLEGED THAT THE FEMORAL STEM WAS LOOSE AND HAD AREAS OF CORROSION BETWEEN THE MODULAR NECK AND FEMORAL STEM.

  Patient problems: Metal Related Pathology

  MAUDE report 11585443 ↗
• InjuryFeb 1, 2021Corroded; Corroded

  ALLEGEDLY, THE PATIENT UNDERWENT REVISION SURGERY DUE TO A FAILED RIGHT TOTAL HIP ARTHROPLASTY WITH BLACK CORROSIVE PRODUCT NOTED ON THE NECK-STEM TAPER.

  Patient problems: Insufficient Information

  MAUDE report 11263319 ↗
• InjuryOct 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO PAIN AND LIMB LENGTH DISCREPANCY IN HER RIGHT HIP. ALL PRODUCTS WERE REPLACED.

  Patient problems: Pain; Unequal Limb Length

  MAUDE report 10750157 ↗