UHR UH1-45-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327016925), received between Apr 6, 2018 and May 14, 2024 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryMay 14, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED AND A SPACER WAS PLACED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 19315700 ↗
• InjuryApr 8, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE BIPOLAR COMPONENT FROM THE PATIENT'S NATIVE ACETABULUM. THE HIP WAS REVISED TO A TOTAL HIP WITH MULTI-HOLE SHELL, SCREWS, LINER AND HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 19059307 ↗
• InjuryApr 1, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. A UNIPOLAR COMPONENT DISLOCATED OUT OF THE PATIENT'S NATIVE ACETABULUM. AFTER A CLOSED REDUCTION HAD FAILED, IT WAS DETERMINED THAT THERE WAS SOFT TISSUE IMPINGEMENT. SURGERY WAS PERFORMED TO CLEAN OUT THE PATIENT'S NATIVE ACETABULUM, AND THE UNIPOLAR COMPONENT WITH FEMORAL HEAD WERE REVISED. 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 19015818 ↗
• InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION. A BIPOLAR COMPONENT AND FEMORAL HEAD WERE REVISED TO ANOTHER BIPOLAR COMPONENT AND FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 18323911 ↗
• InjuryAug 17, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "CONVERSION FROM BIPOLAR TO LTH ARTHROPLASTY. PRE OP DIAGNOSIS: PROSTHETIC LEFT JOINT DISLOCATION." REP CONFIRMED THE BIPOLAR HEAD CAME OUT OF THE PATIENT'S NATIVE ACETABULUM. A FEMORAL HEAD AND BIPOLAR COMPONENT WERE REVISED. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE FEMORAL HEAD AS IT WAS WELL FIXED, CAME OFF TOGETHER WITH THE BIPOLAR COMPONENT.

  Patient problems: Joint Dislocation

  MAUDE report 15238692 ↗
• InjuryAug 3, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY REP: "LEFT HIP CONVERSION BIPOLAR TO TOTAL HIP. DIAGNOSIS: HIP PAIN." REP PROVIDED PRIMARY AND REVISION USAGE SHEETS. SPOKE TO REP, WHO CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON. UPDATE 07/14/2021: THERE ARE NO ALLEGATIONS AGAINST THE REVISED COMPONENTS TO MY KNOWLEDGE. THE DOCTOR CONFIRMED THAT THERE WAS SOME WEAR IN THE ACETABULUM AS WELL AS SOME SOFT TISSUE INFLAMMATION.

  Patient problems: Pain

  MAUDE report 12271594 ↗
• InjuryApr 8, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PT. PRESENTED WITH SYMPTOMS OF AN INFECTION. PT. WAS BROUGHT TO THE OPERATING ROOM FOR AN ¿IRRIGATION & DEBRIDEMENT¿ AND SWAPPING OF BIPOLAR-HEAD COMPONENTS AS PER DR¿S I&D PROTOCOL(S). THE FEMORAL HEAD AND UHR/ UHT BIPOLAR COMPONENT THAT WENT IN ON (B)(6) 2021 WERE REPLACED. THE CEMENTED STEM WAS NOT CHANGED. NO COMPLAINTS FILED AGAINST THE IMPLANTS THEMSELVES." SPOKE TO REP, WHO PROVIDED THE PRIMARY AND REVISION USAGE SHEETS AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Unspecified Infection

  MAUDE report 11633440 ↗
• InjuryFeb 11, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO ACETABULAR PAIN (POSSIBLE CAUSES OR CONTRIBUTORS TO PAIN NOT REPORTED TO REP). A 45X26 UHR BIPOLAR COMPONENT AND 26 +0 LFIT HEAD WERE REVISED TO A 48D TRIDENT II SHELL WITH 1 SCREW, MDM/ADM LINER CONSTRUCT, AND A 22.2 +8 LFIT HEAD. THE STEM WAS NOT REVISED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE.

  Patient problems: Injury; Pain

  MAUDE report 8327850 ↗
• InjuryOct 25, 2018Unstable; Unstable

  IT WAS REPORTED THAT PATIENT'S HIP WAS REVISED DUE TO INSTABILITY. PATIENT WAS CONVERTED FROM A HEMI TO A TOTAL HIP (STEM WAS NOT REVISED).

  Patient problems: Injury

  MAUDE report 8006364 ↗
• InjuryAug 31, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO DISLOCATION OF THE BIPOLAR CONSTRUCT FROM THE PATIENT'S NATIVE ACETABULUM. PATIENT WAS REVISED TO A TOTAL HIP INCLUDING A HEMISPHERICAL SHELL AND SCREWS, ADM/MDM LINER CONSTRUCT, AND AN LFIT METAL HEAD (STEM WAS NOT REVISED).

  Patient problems: Injury; Joint Dislocation

  MAUDE report 7838398 ↗
• InjuryApr 6, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED FROM A HEMI TO A TOTAL CONSTRUCT AFTER PATIENT SUSTAINED A FALL AND THE ENTIRE HEMI CONSTRUCT CAME OUT OF THE PATIENT'S ACETABULUM TWICE THEREAFTER. STEM WAS WELL-FIXED AND WELL-POSITIONED AND REMAINED IN PATIENT.

  Patient problems: Fall; Injury; Joint Dislocation

  MAUDE report 7403760 ↗