EMPHASYS 4722-54-040Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 10603295500377), received between Jan 3, 2024 and Sep 16, 2026 — classified as 20 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (6 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• InjurySep 16, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that the patient was revised due to exhibited sign of infection, so the surgeon performed a liner and head exchange.Affected side: Left Hip

  Patient problems: Unspecified Infection

  MAUDE report 50787786 ↗
• InjuryMay 14, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED THEIR HIP IN PACU AND WAS BROUGHT BACK TO THE OPERATING ROOM TO EXCHANGE COMPONENTS FOR DUAL MOBILITY. DOI: UNKNOWN. DOR: (B)(6) 2026. AFFECTED SIDE: UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 25173924 ↗
• InjuryApr 27, 2026Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE LEFT IS THE AFFECTED SIDE AND PATIENT PUSHED TOO HARD TOO FAST AFTER SURGERY AND WASN'T FULLY HEALED BEFORE RESUMING REGULAR PHYSICAL ACTIVITY.

  Patient problems: Joint Dislocation; Joint Laxity

  MAUDE report 25003402 ↗
• InjuryJan 12, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT ON (B)(6) 2025 THE PATIENT HAD NATIVE INFECTED HIP. A SPACER WAS PLACED TO TREAT INFECTION. PATIENT WAS INFECTED AGAIN SO THE SPACER WAS REMOVED ON (B)(6) 2025. A NEW SPACER WAS PLACED ON THIS DATE. AFFECTED SIDE-UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24034754 ↗
• InjuryJan 6, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS REVISED AS PATIENT WAS THOUGHT TO BE INFECTED. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23976166 ↗
• InjuryJan 5, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT WAS SEPTIC. DURING AN ATTEMPTED IRRIGATION AND DEBRIDEMENT, THE INFECTION WAS FOUND TO BE WORSE THAN ANTICIPATED, LEADING TO THE REMOVAL OF ALL IMPLANTS AND PLACEMENT OF ABX (ANTIBIOTIC) SPACER BLOCKS FOR A PLANNED STAGED REVISION. ALL DEVICES WERE EXPLANTED WITHOUT DIFFICULTY. AFTER IMPLANTATION AND REDUCTION OF THE ANTIBIOTIC SPACER, THE PATIENT WAS CODED. DOI: ON (B)(6) 2025, DOR: UNKNOWN, AFFECTED SIDE: UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 23966444 ↗
• InjuryDec 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THAYER SCHOOL OF ENGINEERING AT DARTMOUTH FIRST REPORT OF RETRIEVALS FOR STATEMENT OF WORK FOR Q4 OF 2025. DARTMOUTH IS THE RESEARCH LOCATION, AND NOT THE FACILITY OF PLACEMENT. A DEPUY SYNTHES IMPLANT WAS REVISED AND REVIEWED FOR ANALYSIS. REASON FOR REVISION: REVISION FOR INFECTION AND PAIN. THE ARTICULAR SURFACE OF THE CERAMIC FEMORAL HEAD SHOWS MINOR METAL TRANSFER.

  Patient problems: Pain; Unspecified Infection

  MAUDE report 23933681 ↗
• InjuryDec 3, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT WASH OUT AND HEAD AND LINER SWAP DUE TO QUESTIONABLE FLUID DISCHARGE FROM WOUND. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Fluid Discharge

  MAUDE report 23705496 ↗
• InjuryDec 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT NEEDED AND I&D, SURGEON WASHED OUT THE WOUND AND CHANGED THE HEAD AND LINER. DOI- (B)(6) 2025, DOR- (B)(6) 2025, AFFECTED SIDE-RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23687289 ↗
• InjuryOct 16, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO HEMATOMA. DOI: (B)(6) 2024, DOR: (B)(6) 2025, AFFECTED SIDE: UNKNOWN.

  Patient problems: Hematoma

  MAUDE report 23316586 ↗
• InjuryAug 5, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS DISLOCATING BECAUSE OF A STIFF SPINE AND SPINAL HARDWARE ALL THE WAY UP. SURGEON REVISED THE CUP AND CHANGED THE VERSION AND INCLINATION ON THE CUP. NO TIME ADDED. DOI: (B)(6) 2025. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Joint Dislocation; Muscular Rigidity

  MAUDE report 22715849 ↗
• InjuryJul 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AS PER SURGEON THE PATIENT HAS INFECTED HIP. SURGEON DID IRRIGATION AND DEBRIDEMENT. RETAINED ALL COMPONENTS AND EXCHANGED HEAD AND LINER. DOI: (B)(6) 2025 DOR: (B)(6) 2025 AFFECTED SIDE: LEFT HIP.

  Patient problems: Fluid Discharge; Unspecified Infection

  MAUDE report 22577031 ↗
• MalfunctionJun 26, 2025Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  IT WAS REPORTED THAT UPON OPENING THE LINER THE SURGEON NOTICED A LONG THIN STRING OF WHAT APPEARED TO BE POLY STILL ATTACHED TO THE LINER. THE SURGEON DID NOT WANT TO IMPLANT BE USED. SURGEON WAS UNSURE IF THE INTEGRITY OF THE POLY WAS COMPROMISED. DOE: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22342102 ↗
• InjuryJun 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT RECENTLY HAD A TOTAL HIP DONE AND FELL. PATIENT TOLD THE SURGEON WHEN PATIENT FELL. PATIENT HEARD A POP. THE SURGEON WAS CONCERNED BECAUSE OF HER HIGH BMI AND HE GOT AN MRI. ON THE MRI SCAN, SURGEON THOUGHT HE SAW A FRACTURE OF THE ACTIS STEM AT THE NECK. HOWEVER, ON THE REVISION SURGERY AND OPENING UP THE PATIENT, THE ACTIS STEM WAS PERFECTLY FINE. SURGEON TOOK THE NOISE THE PATIENT TOLD HIM AS POSSIBLY THE GREATER TROC BREAKING. SURGEON DID HOWEVER REMOVE THE STEM, HEAD, AND POLY BECAUSE HE HAD SUSPICION OF INFECTION. THERE WERE NO ISSUES WITH ANY OF OUR PRODUCTS. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Unspecified Infection

  MAUDE report 22319077 ↗
• InjuryJun 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED WITH IRRIGATION AND DEBRIDEMENT OF HIP. MODULAR COMPONENTS SWAPPED WHILE IN CAPSULE. DOI: UNKNOWN. DOR: ON (B)(6) 2025. AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Insufficient Information

  MAUDE report 22307026 ↗
• InjuryMay 22, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT WAS REVISED FOR DISLOCATED HIP. AFFECTED SIDE: LEFT.

  Patient problems: Joint Dislocation

  MAUDE report 22069107 ↗
• InjuryFeb 11, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT WAS REVISED DUE TO DISLOCATION. POST SURGERY, PATIENT FELL AND DISLOCATED THE HIP. SINCE THE ORIGINAL FALL, THE PATIENT HAS HAD OTHER DISLOCATIONS, WHICH REQUIRED HIS HIP TO BE REVISED. AFFECTED SIDE: LEFT HIP.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 21354029 ↗
• InjuryJan 23, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT FELL AND NEEDED REVISION OF A PROSTALAC STEM/LINER AND PLACEMENT OF ANOTHER PROSTALAC. THE FALL FRACTURED BONE AND LOOSENED THE CUP AND STEM. THE PRODUCTS NEEDED TO BE REVISED FOR STABILITY PURPOSES. DOI: (B)(6) 2024. DOR: (B)(6) 2024. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Fall; Joint Laxity

  MAUDE report 21217616 ↗
• InjuryNov 26, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE DOCTOR REMOVED THE COMPONENTS LISTED AS A PART OF THE REVISION. THE PATIENT DISLOCATED THEIR HIP A FEW HOURS AFTER THE INITIAL SURGERY. THE SURGEON THEN REIMPLANTED THE NEW COMPONENTS. DOI: (B)(6). DOR: (B)(6) 2024. AFFECTED SIDE: UNKNOWN HIP SIDE.

  Patient problems: Joint Dislocation

  MAUDE report 20785267 ↗
• InjuryAug 5, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION WAS RECEIVED AND STATED THAT THERE ARE NO REPORTS OF ANY PATIENT HARM AND SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 19906700 ↗
• InjuryJan 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE PATIENT WAS REVISED DUE TO INFECTION. UNKNOWN SURGICAL DELAY. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 18435663 ↗