NA 802203605Recalls & reported problems

Summary

The FDA's MAUDE database contains 6 adverse event reports that list this exact device (DI 00889024498914), received between Aug 1, 2025 and May 19, 2026 — classified as 4 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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 6 most recent of 6 reports, in the reporter's own words as published by the FDA.

• InjuryMay 19, 2026Device Dislodged or Dislocated

  IT WAS REPORTED THAT A PATIENT UNDERWENT AN INITIAL HIP PROCEDURE ON AN UNKNOWN DATE. SUBSEQUENTLY THE PATIENT WAS REVISED DUE TO INFECTION, DISLOCATION AND LOOSENING OF THE STEM. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Dislocation; Medical device site infection; Septic loosening

  MAUDE report 25215941 ↗
• InjuryMar 9, 2026Device Dislodged or Dislocated

  NO ADDITIONAL INFORMATION AVAILABLE FOR THE REPORTED EVENT.

  Patient problems: Joint Dislocation

  MAUDE report 24544289 ↗
• MalfunctionJan 5, 2026Delivered as Unsterile Product; Device Damaged Prior to Receipt by User

  IT WAS REPORTED THAT THE OUTER PACKAGE APPEARED DISTRESSED AND NOT VISIBLY DAMAGED. THERE WERE RATTLING FRAGMENTS COMING FROM INSIDE THE SEALED BOX DUE TO DAMAGED INNER PACKAGING. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23955303 ↗
• MalfunctionDec 17, 2025Manufacturing, Packaging or Shipping Problem; Manufacturing, Packaging or Shipping Problem

  IT WAS REPORTED THAT A BOXED IMPLANT WAS NOTED TO HAVE AN AUDIBLE LOOSE COMPONENT INSIDE WHILE THE IMPLANT REMAINED STERILE SEALED AND WRAPPED. THE ISSUE WAS IDENTIFIED DURING RECEIVING INSPECTION AFTER THE PRODUCT RETURNED FROM A REMOTE ACCOUNT, WITH RATTLING HEARD INSIDE THE BOX. THERE WAS NO PATIENT INVOLVEMENT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23827068 ↗
• InjurySep 2, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY. SURGEON WAS CONCERNED FOR DISLOCATION RISK AFTER THE PREVIOUS INFECTION WAS BROUGHT UNDER CONTROL. HEAD AND LINER EXCHANGED WITH A WASHOUT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 22938661 ↗
• InjuryAug 1, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY SIX MONTHS POST-IMPLANTATION, THE PATIENT UNDERWENT A HIP REVISION DUE TO INSTABILITY. SURGEON WAS CONCERNED FOR DISLOCATION RISK AFTER THE PREVIOUS INFECTION WAS BROUGHT UNDER CONTROL. HEAD AND LINER EXCHANGED WITH A WASHOUT. ATTEMPTS HAVE BEEN MADE AND NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Joint Laxity

  MAUDE report 22693379 ↗