PROFEMUR® PHAC1234Recalls & reported problems

Summary

The FDA's MAUDE database contains 10 adverse event reports that list this exact device (DI M684PHAC12341), received between Jul 28, 2020 and Jul 24, 2024 — classified as 10 injuries.

The most frequently reported specific device problem is “Break” (3 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 10 most recent of 10 reports, in the reporter's own words as published by the FDA.

• InjuryJul 24, 2024Break; Mechanical Problem; Break; Mechanical Problem

  ALLEGEDLY, MODULAR NECK FRACTURE. VERY DIFFICULT STEM REMOVAL ETO REQUIRED BONE HAD GROWN INTO SPLINES. WE REPLACED CUP WITH DYNASTY DUAL MOBILITY.

  Patient problems: Insufficient Information; Pain

  MAUDE report 19823128 ↗
• InjurySep 26, 2022Patient-Device Incompatibility; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT RECEIVED A LEFT HIP PROSTHESIS ON (B)(6) 2015 AND A RIGHT HIP PROSTHESIS ON (B)(6) 2016, BOTH WERE PERFORMED AT HOSPITAL (B)(6). DURING 2017, PATIENT SUFFERED HIS FIRST HIP DISLOCATION. THEN, DURING 2018, PATIENT SUFFERED A SECOND DISLOCATION. ON THE SAME YEAR, 2018, THE PATIENT WAS DIAGNOSED WITH A PSEUDOTUMOR. PATIENT SUFFERED AN ADVERSE REACTION TO THE METAL COMING FROM THE IMPLANTED DEVICES. IT IS TO NOTE THAT PATIENT IS ALLERGIC TO COBALT AND THAT THE PROSTHESIS REMAINS IMPLANTED IN PATIENT. REPORTER STATED ON INITIAL EMAIL NOTIFICATION THAT THIS WAS A CASE IMPLANTED IN 2015 WITH CONFIRMED METALLOSIS IN POSTERIOR ANALYSIS.

  Patient problems: Metal Related Pathology

  MAUDE report 15487937 ↗
• InjurySep 2, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, THE ACETABULAR COMPONENT WAS INSERTED AS A REVISION FOR A PREVIOUSLY MIGRATED PROCOTYL L SHELL. REVISION COMPONENT INSERTED IN ROUTINE FASHION AND SECURED WITH 3X SCREWS. SHELL INSERTION AND SCREW INSERTION APPEARED SECURE AT COMPLETION OF PROCEDURE. PATIENT SEEN IN ROUTINE FOLLOW UP CLINIC AT 3 MONTHS JUST 2 DAYS BEFORE READMISSION WITH FURTHER MIGRATION OF REVISION ACETABULAR COMPONENT. PATIENT DENIES ANY TRAUMATIC EVENT. THE PREVIOUS REVISION IS CAPTURED UNDER INCIDENT GROUP (B)(4). ADDITIONAL INFORMATION: ALLEGEDLY, AS REPORTED FROM UK NJR REGISTRY DATA, THIS PATIENT WAS REVISED DUE TO DISLOCATION AND/OR SUBLUXATION AND INFECTION. SRNJR REFERENCE: (B)(4).

  Patient problems: Unspecified Infection

  MAUDE report 15351254 ↗
• InjuryJul 6, 2022Corroded; Corroded

  ALLEGEDLY, THE PATIENT WAS REVISED IN THE RIGHT SIDE DUE TO CORROSION.

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

  MAUDE report 14934217 ↗
• InjuryMay 12, 2022Corroded; Corroded

  ALLEGEDLY PT. NOW HAS ELEVATED METAL IONS. ORIGINALLY PART OF IDE / CERAMIC ON METAL ARTICULATION SYSTEM CLINICAL STUDY BUT NOT ANY LONGER. ADDITIONAL INFORMATION RECEIVED ON (B)(6) 2022: PATIENT DEVELOPED ADVERSE SYMPTOMS INCLUDING, BUT NOT LIMITED TO, PROGRESSIVELY WORSENING PAIN IN AND AROUND HIS RIGHT HIP JOINT, AS WELL AS NEUROLOGIC SYMPTOMS INCLUDING PERIPHERAL NEUROPATHY, TINNITUS, SOME BALANCE/COORDINATION ISSUES, A HEAL FRACTURE AS A DIRECT RESULT OF THOSE BALANCE/COORDINATION ISSUES, AND B 12 DEFICIENCY. LABORATORY TEST RESULTS REPORTED ON (B)(6) 2020, REVEALED ELEVATED SERUM CHROMIUM AND BLOOD COBALT LEVELS IN PATIENT. ON (B)(6) 2021, PATIENT HAD A REVISION SURGERY PERFORMED ON HIS RIGHT HIP BY (B)(6) M.D., AT (B)(6) HOSPITAL, (B)(6). EARLY IN HIS (B)(6) 2021, OPERATIVE REPORT, DR. JONES NOTED, "METALLOSIS DEBRIS AT THE EXTERNAL ROTATORS." AFTER REMOVAL OF THE CONSERVE® FEMORAL HEAD FROM THE PROFEMUR® PLUS MODULAR NECK, DR. (B)(6) NOTED "A FAIR AMOUNT OF BLACK CORROSION DISCOLORATION AT THE TAPER ON BOTH COMPONENTS." IN THE (B)(6) 2021, REVISION SURGERY, DR. (B)(6), REMOVED THE WRIGHT MEDICAL PROFEMUR® HIP SYSTEM, INCLUDING THE PROFEMUR® PLUS COCR MODULAR NECK AND PROFEM

  Patient problems: Metal Related Pathology; Neuropathy; Pain

  MAUDE report 14378451 ↗
• InjuryApr 26, 2022Corroded; Corroded

  ALLEGEDLY, PATIENT UNDERWENT LEFT HIP REVISION SURGERY FOR THE PROFEMUR® TOTAL HIP SYSTEM (STEM & NECK) DUE TO CORROSION AT THE NECK-STEM JUNCTION OF THE DEVICE, LACK OF MOBILITY AND PAIN. IT WAS NOT INDICATED IF THE ACETABULAR COMPONENTS WERE REVISED.

  Patient problems: Loss of Range of Motion; Pain

  MAUDE report 14213051 ↗
• InjuryFeb 8, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ALLEGEDLY, PATIENT WAS REVISED DUE TO DISLOCATION/SUBLUXATION. REVISION NJR NUMBER: (B)(6). SIDE: R. PRIMARY ASA: P2 - MILD DISEASE NOT INCAPACITATING.

  Patient problems: Insufficient Information

  MAUDE report 13484097 ↗
• InjuryMay 4, 2021Break; Break

  ALLEGEDLY, THE PATIENT WAS REVISED DUE TO FEMORAL NECK FAILED BREAKING IN TWO PIECES AT THE NECK-STEM JUNCTION.

  Patient problems: Insufficient Information

  MAUDE report 11773358 ↗
• InjuryJan 7, 2021Break; Break

  ALLEGEDLY, NECK BROKE. (BIG MALE PATIENT OVER (B)(6) LBS) ADDITIONAL INFORMATION RECEIVED ON 12/14/2020: PRODUCT INFORMATION, REVISION FACILITY AND DATE OF INCIDENT AND REVISION.

  Patient problems: Bone Fracture(s)

  MAUDE report 11131183 ↗
• InjuryJul 28, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  ALLEGEDLY, PATIENT WAS REVISED DUE TO ASEPTIC LOOSENING STEM AND ADVERSE SOFT TISSUE REACTION TO PARTICLE DEBRIS. REVISION NJR NUMBER: 4458878. SIDE:L. PRIMARY ASA: P1 - FIT AND HEALTHY. COMPONENTS NOT REVISED: PROCOTYL L BEADED AND HA COATED CUP SIZE 50MM, PRODUCT ID: PHA06260, LOT ID: 1521597. RIM-LOCK BIOLOX DELTA CERAMIC LINER 32MM ID GROUP D, PRODUCT ID: PHA04508, LOT ID: 1549402.

  Patient problems: Reaction

  MAUDE report 10335406 ↗