EMPHASYS 4722-48-436Recalls & reported problems

Summary

The FDA's MAUDE database contains 15 adverse event reports that list this exact device (DI 10603295501077), received between Jul 17, 2023 and Sep 16, 2026 — classified as 15 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 15 most recent of 15 reports, in the reporter's own words as published by the FDA.

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

  Patient problems: Unspecified Infection

  MAUDE report 50792582 ↗
• InjuryFeb 24, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT COMES BACK IN AFTER DISLOCATING. THE DOCTOR FOUND IT BEST TO REMOVE THE CUP AND CHANGE THE POSITION OF IT. HE WENT WITH AN EDM CONSTRUCT FOR ADDED STABILITY AS WELL. NO FURTHER PATIENT INFORMATION IS AVAILABLE AT THIS TIME.

  Patient problems: Joint Dislocation

  MAUDE report 24425669 ↗
• InjuryFeb 10, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IRRIGATION AND DEBRIDEMENT(I&D). AFFECTED SIDE: RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 24304088 ↗
• InjuryOct 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT HAD AN IRRIGATION, DEBRIDEMENT AND A HEAD AND LINER EXCHANGE FOR CONFIRMED INFECTION. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23349209 ↗
• InjurySep 16, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  ADDITIONAL INFORMATION RECEIVED STATES THAT THE AFFECTED SIDE INVOLVED IN THIS EVENT WAS THE RIGHT HIP.

  Patient problems: Insufficient Information

  MAUDE report 23064530 ↗
• InjuryMar 31, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE IMPLANTS WERE REMOVED DUE TO INFECTION. THERE WAS NO SURGICAL DELAY. AFFECTED SIDE: RIGHT HIP

  Patient problems: Unspecified Infection

  MAUDE report 21733715 ↗
• InjuryFeb 7, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT UNDERWENT REVISION OF TOTAL HIP FOR INFECTION. SURGICAL DELAY WAS UNKNOWN. DOI: (B)(6) 2024. DOR: (B)(6) 2025. AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 21332981 ↗
• InjuryNov 20, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ADDITIONAL INFORMATION RECEIVED STATES THAT THERE WAS NO SURGICAL DELAY.

  Patient problems: Unspecified Infection

  MAUDE report 20736753 ↗
• InjuryOct 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: DOTS. IT WAS REPORTED THAT THE STUDY PATIENT UNDERWENT SURGERY FOR THE LEFT KNEE. CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR - PE. DEVICE RELATED: DEFINITELY NOT. PROCEDURE RELATED: PROBABLY. DATE OF EVENT: AUGUST 20, 2024. TREATMENT/IMPACT: NO INFORMATION PROVIDED.

  Patient problems: Pulmonary Embolism

  MAUDE report 20438307 ↗
• InjuryJun 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6). CLINICAL ADVERSE EVENT RECEIVED FOR VASCULAR DVT. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2024. DATE OF EVENT: 12 JUN 2024. (LEFT KNEE). TREATMENT: ORAL MEDICATION.

  Patient problems: Thrombosis/Thrombus

  MAUDE report 19624844 ↗
• InjuryFeb 15, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SUBJECT ID: (B)(6). STUDY NO: (B)(6) CLINICAL ADVERSE EVENT RECEIVED FOR INFECTION - SUPERFICIAL. EVENT IS SERIOUS AND IS CONSIDERED MILD. EVENT IS POSSIBLY RELATED TO PROCEDURE. EVENT IS NOT RELATED TO DEVICE. DATE OF IMPLANT: (B)(6) 2023 DATE OF EVENT: (B)(6) 2024 (RIGHT HIP) TREATMENT: IRRIGATION AND DEBRIDEMENT

  Patient problems: Unspecified Infection

  MAUDE report 18711413 ↗
• InjurySep 7, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT DISLOCATED HIP TWICE. CHANGED POLY TO AN ELEVATED RIM AND THE HEAD FROM A +3 TO A +6. NO SURGICAL DELAY WAS THERE. DOI: (B)(6) 2023. DOR: (B)(6) 2023. AFFECTED SIDE: RIGHT HIP.

  Patient problems: Joint Dislocation

  MAUDE report 17697956 ↗
• InjuryAug 28, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CLINICAL NOTIFICATION RECEIVED FOR REVISION DUE TO MALPOSITION/NON UNION TROCHANTER. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: (B)(6) 2023. (RIGHT HIP). TREATMENT: HEAD, LINER, STEM, AND CUP WERE REVISED.

  Patient problems: Fall; Hematoma; Pain

  MAUDE report 17632762 ↗
• InjuryAug 23, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL ADVERSE EVENT RECEIVED FOR DISLOCATION. EVENT IS SERIOUS AND IS CONSIDERED MODERATE. EVENT IS POSSIBLY RELATED TO BOTH DEVICE AND PROCEDURE. DATE OF IMPLANT: (B)(6) 2023. DATE OF REVISION: (B)(6) 2023. DATE OF EVENT: (B)(6) 2023. (LEFT HIP). TREATMENT: REVISION (REVISED IMPLANTS NOT SPECIFIED).

  Patient problems: Joint Dislocation

  MAUDE report 17603901 ↗
• InjuryJul 17, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  CLINICAL NOTES & OPERATIVE NOTES RECEIVED. ON (B)(6) 2023 THE PATIENT HAD A LEFT TOTAL HIP ARTHROPLASTY TO ADDRESS OSTEOARTHRITIS. DEPUY COMPONENTS WERE IMPLANTED DURING THIS PROCEDURE. ON (B)(6) 2023 MEDICAL RECORDS NOTE THE PATIENT HAD WAS STATUS POST LEFT ANTERIOR HIP REPLACEMENT WITH DISLOCATION. IT WAS NOTED THAT 6 WEEKS AGO, THE PATIENT DISLOCATED THEIR HIP AND HAD A REDUCTION.

  Patient problems: Joint Dislocation

  MAUDE report 17332197 ↗