UHR UH1-52-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07613327017168), received between May 25, 2017 and May 11, 2026 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (3 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. How this data works · Data updated Oct 13, 2026.

Recalls naming this device

1. Jul 30, 2026Open, 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-3197-2026 · Root cause: Process change control · FDA record ↗

Most reported problems

Recent adverse event reports

The 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryMay 11, 2026Device Dislodged or Dislocated

  THE FOLLOWING INFORMATION WAS PROVIDED: RIGHT HIP REVISION. PT. PRESENTED WITH A DISLOCATED RIGHT-HIP, FOLLOWING A BIPOLAR/HEMI GMRS PROXIMAL-FEMUR REPLACEMENT ON (B)(6) 2025. DR. OPTED TO REVISE THE CONSTRUCT TO A TOTAL HIP AS WELL AS RESECT MORE NATIVE FEMUR BONE. ALL COMPONENTS WERE EXPLANTED. NO COMPLAINTS FILED AGAINST THE COMPONENTS THEMSELVES, NO FURTHER INFO.

  Patient problems: Joint Dislocation

  MAUDE report 25136678 ↗
• InjuryNov 20, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BIPOLAR HEAD DISENGAGED FROM V40 HEAD AND STEM. SURGEON CONVERTED TO A TOTAL HIP WITH TRITANIUM CUP AND MDM. HOSPITAL IS NOT RELEASING ANY MORE INFORMATION REGARDING THE CASE.

  Patient problems: Joint Dislocation

  MAUDE report 18171461 ↗
• InjuryNov 11, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  CONVERSION FROM BIPOLAR TO A RIGHT TOTAL HIP.

  Patient problems: Insufficient Information

  MAUDE report 12801152 ↗
• InjuryMay 25, 2017Device Dislodged or Dislocated; Insufficient Device Problem Information; Insufficient Device Problem Information

  SALES REP REPORTED A REVISION OF THE LEFT HIP. PATIENT WAS A RECURRENT DISLOCATOR AND WAS CONVERTED FROM A BIPOLAR TO A TOTAL HIP.

  Patient problems: Failure of Implant; Injury; Joint Dislocation

  MAUDE report 6591646 ↗