UHR UH1-45-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 07613327016918), received between Feb 27, 2017 and Sep 24, 2025 — classified as 9 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (4 reports).

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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE FOLLOWING INFORMATION WAS PROVIDED: LEFT HIP. REVISION SECONDARY TO A PAINFUL BIPOLAR HIP REPLACEMENT. THE BIPOLAR HEAD WAS REMOVED, A CUP WAS IMPLANTED AND MDM HEAD FOR STABILITY. NO FURTHER INFORMATION IS AVAILABLE FROM THE DOCTOR OR HOSPITAL.

  Patient problems: Pain

  MAUDE report 23131590 ↗
• InjuryNov 15, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED BY SALE REP THAT THERE WAS A BIPOLAR REVISION CASE PERFORMED ON (B)(6) 2023 FOR DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 18138308 ↗
• InjuryDec 14, 2021Use of Device Problem; Insufficient Device Problem Information; Use of Device Problem; Insufficient Device Problem Information

  AFTER BHA, DISTRIBUTER CHECKED THE SIZE AND FOUND A UHR WITH 28MM INNER DIAMETER WAS USED ON 26MM HEAD. SALES REP WAS NOT PRESENT. UPDATE 04-MAR-2022: PATIENT WAS REVISED ON (B)(6) 2021.

  Patient problems: Insufficient Information

  MAUDE report 13006668 ↗
• InjuryDec 8, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED: "REVISION OF RIGHT BIPOLAR HIP TO TOTAL HIP FOR PAIN." PATIENT WAS REVISED FROM A C-TAPER LFIT HEAD WITH UHR BIPOLAR COMPONENT TO A C-TAPER CERAMIC HEAD WITH TRIDENT POLY INSERT AND TRIDENT CLUSTER HOLE SHELL.

  Patient problems: Pain

  MAUDE report 12965421 ↗
• InjuryMar 10, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BHA WAS PERFORMED ABOUT A MONTH AGO. PATIENT FALL CAUSED DISLOCATION. WHEN MANUAL REDUCTION WAS DONE, V40 DISLOCATED FROM UH1. STEM AND HEAD REMAINED AND UH1 WAS REVISED. CUSTOMER WANTS TO KNOW IF THERE IS ANY PROBLEM WITH FIXATION STYLE OF UH1.

  Patient problems: Ambulation or Postural Difficulties

  MAUDE report 11452983 ↗
• InjuryJan 11, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISASSOCIATION OF UHR BIPOLAR COMPONENT, AND INNER 28MM HEAD DUE TO FALL.

  Patient problems: Joint Dislocation

  MAUDE report 11145924 ↗
• InjuryDec 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT HAD HIP JOINT SPACE INFECTION. OMNIFIT HFX [WITH COCR FEMORAL HEAD] AND BIPOLAR COMPONENTS EXPLANTED...NO COMPLICATIONS. NO VISUAL COMPLICATIONS OR DAMAGE WITH EXPLANTS. NO PREVIOUS REPORTS AVAILABLE." REP PROVIDED X-RAYS AND EXPLANT PICTURES.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 9433484 ↗
• InjurySep 23, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A PATIENT UNDERWENT A HIP REPLACEMENT ON (B)(6) 2016. BIPOLAR WAS IMPLANTED INTO THE PATIENT. THE PATIENT FILED A LAWSUIT TO HOSPITAL DUE TO INFECTION AFTER OPERATION. IT WAS NOT REPORTED THAT REVISION SURGERY WAS OPERATED OR NOT.

  Patient problems: Unspecified Infection

  MAUDE report 9105193 ↗
• InjuryFeb 27, 2017Device Dislodged or Dislocated

  A HEMIARTHROPLASTY WAS RETURNED TO THE OPERATING ROOM WHEN POST OP X-RAYS SHOWED THE HIP HAD DISLOCATED. SURGEON DOWNSIZED THE BIPOLAR HEAD FROM A 45 MM TO A 44 MM AND REDUCED THE HIP.

  Patient problems: Injury; Joint Dislocation; No Known Impact Or Consequence To Patient

  MAUDE report 6362584 ↗