EMPHASYS 4722-52-236Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 10603295501336), received between Dec 24, 2025 and Apr 30, 2026 — classified as 3 injuries.

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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 30, 2026Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT EMSYS LNR AOX ELV 52X36, UNK HIP FEMORAL HEAD CERAMIC, EMSYS SHL 3HOLE 52, PINN CAN BONE SCREW 6.5MMX35MM, AND UNKNOWN SCREW WERE INVOLVED IN A REPORTED EVENT. THE EVENT CONCERNED A PATIENT WHO UNDERWENT A DAIR (DEBRIDEMENT, ANTIBIOTICS, AND IMPLANT RETENTION) PROCEDURE DUE TO INFECTION FOLLOWING IMPLANTATION OF AN EMPHASYS CORAIL CONSTRUCT. DURING THE OPERATION, THE CUP WAS DESCRIBED AS LOOSE, BUT IT WAS NOT REMOVED BECAUSE THE PATIENT WAS LIKELY TO REQUIRE A MULTI-STAGE REVISION AND SCREWS WERE ALREADY IN PLACE. THE REPORTED FAILURE INCLUDED INFECTION AND IMPLANT LOOSENING. THE PATIENT EXPERIENCED HARM, REQUIRING REVISION OF THE LINER AND IMPLANTATION OF A NEW FEMORAL HEAD AS PART OF THE WASHOUT FOR INFECTION. EXTENDED HOSPITALIZATION WAS NECESSARY FOR SURGICAL INTERVENTION TO ADDRESS THE INFECTION. THE EVENT IS LIKELY TO RESULT IN FURTHER MULTI-STAGE REVISION PROCEDURES. THE IMPLANT STATUS FOR THE LINER AND FEMORAL HEAD IS EXPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 25045798 ↗
• InjuryMar 13, 2026Adverse Event Without Identified Device or Use Problem

  PATIENT WAS REVISED DUE TO INFECTION. HEAD BALL AND POLY WERE EXCHANGED. DOI: UNKNOWN, DOR: (B)(6) 2026, AFFECTED SIDE: UNKNOWN HIP.

  Patient problems: Unspecified Infection

  MAUDE report 24594963 ↗
• InjuryDec 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT BECAME INFECTED ABOUT 4 WEEKS POST OP. DOCTOR OPTED TO PULL HARDWARE, RUN LABS AND USE AND MEDICATED TEMP SPACER. DOI: UNKNOWN, DOR: (B)(6) 2025, AFFECTED SIDE: LEFT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 23888194 ↗