UHR UH1-47-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07613327016987), received between Feb 21, 2019 and Oct 9, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 FDA recall record name this device's identifier, 1 still open.

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 18, 2026.

Recalls naming this device

1. Jul 30, 2026Class IIOpen, Classified

   Affected devices were manufactured with Ultra High Molecular Weight Polyethylene (UHMWPE) raw material aged in excess of five years. Product has the potential for elevated levels of oxidation, which may result in increased wear, leading to hazards such as excessive wear debris, material fragments, fractured device, or disassociated device. Potential harms include revision surgery, pain, and inflammation.

   Z-3199-2026 · Root cause: Process change control · Recall details · FDA record ↗

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.

• InjuryOct 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S HIP WAS REVISED. NOTED ON THE SHEET: "SIMPLE POSSIBLE INFECTION. CHANGED HEAD & BIPOLAR." AS REPORTED BY REP: "WOUND LITTLE SUSPICIOUS & DOCTOR WASHED OUT THE WOUND & CHANGED THE HEAD & BIPOLAR SHELL/LINER. NURSING HOME PT." RIGHT HIP.

  Patient problems: Unspecified Infection

  MAUDE report 17893044 ↗
• InjuryDec 20, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION USAGE SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "PATIENT WAS DISLOCATED. REMOVED COMPONENTS AND PUT IN SMALLER STEM AND SHORTER NECK. NOTHING IS AVAILABLE PER HOSPITAL." SPOKE TO REP. THE BIPOLAR HEAD DISLOCATED OUT OF THE PATIENT'S ACETABULUM. SURGEON REPORTED THAT THE ORIGINALLY IMPLANTED STEM WAS TOO LONG FOR THE PATIENT'S ANATOMY. THE PATIENT'S ENTIRE HEMI HIP CONSTRUCT WAS REVISED TO ANOTHER HEMI HIP CONSTRUCT. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 11043063 ↗
• InjuryFeb 21, 2019Unstable; Unstable

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED FROM A HEMI TO A TOTAL HIP 4 DAYS POST-OP DUE TO INSTABILITY. POSSIBLE CAUSE OR CONTRIBUTOR TO INSTABILITY WAS NOT REPORTED TO THE REP. A 47X26 BIPOLAR COMPONENT AND 26 -3 METAL HEAD WERE REVISED TO A TOTAL HIP CONSTRUCT WITH A 54MM SHELL AND SCREW, ADM/MDM LINER CONSTRUCT, AND BIOLOX CERAMIC HEAD. THE SIZE 6 ACCOLADE II STEM WAS NOT REVISED.

  Patient problems: Injury

  MAUDE report 8360055 ↗