UHR UH1-46-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327016956), received between May 8, 2018 and Dec 5, 2023 — classified as 5 injuries, 2 malfunctions.

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. 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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  BHA WAS PERFORMED FOR LEFT FEMORAL NECK FRACTURE ON (B)(6)2023. ON NOVEMBER 10, 2023, DISLOCATION WAS CONFIRMED. DURING THE DOCTOR ATTEMPTED TO REPOSITIONING THE DEVICE, THE INNER HEAD WAS DISLOCATED FROM THE UHR BIPOLAR CUP. THUS, THE REVISION SURGERY WAS PERFORMED ON (B)(6) 2023.

  Patient problems: Joint Dislocation

  MAUDE report 18266062 ↗
• InjuryMay 9, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  DISLOCATION DUE TO PATIENT FALL. IT COULD NOT BE REDUCED AT ANOTHER HOSPITAL. DURING REDUCTION THE BIPOLAR CUP AND HEAD CAME OFF. THE BIPOLAR CUP AND HEAD WERE REPLACED.

  Patient problems: Fall

  MAUDE report 14335816 ↗
• InjuryApr 8, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED DUE TO INFECTION. AN IRRIGATION AND DEBRIDEMENT WAS PERFORMED, AND A BIPOLAR COMPONENT AND FEMORAL HEAD WERE EXCHANGED FOR ITEMS OF THE SAME CATALOG NUMBERS.

  Patient problems: Unspecified Infection

  MAUDE report 14050242 ↗
• InjuryMar 14, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  THE 46MM BIPOLAR AND 28MM INNER HEAD DISASSOCIATED DURING REDUCTION AFTER THE PATIENT DISLOCATED POST OPERATIVELY. PATIENT WAS REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 13757893 ↗
• InjuryMay 11, 2020Fracture; Fracture

  PROCEDURE: THE PATIENT HAD A LEFT FEMORAL NECK FRACTURE AND UNDERWENT INSERTION OF ANTIBIOTICS AS A DRUG DELIVERY DEVICE FOR LEFT HIP HEMIARTHROPLASTY (B)(6) 2019. THE PATIENT HAD IRRIGATION AND DEBRIDEMENT OF LEFT HIP DEEP HEMATOMA. PATIENT UNDERWENT REVISION LEFT TOTAL HIP ARTHROPLASTY, SINGLE COMPONENT CHANGED (B)(6) 2019.

  Patient problems: Hematoma; Injury

  MAUDE report 10043600 ↗
• MalfunctionDec 28, 2018Device Difficult to Setup or Prepare; Device Difficult to Setup or Prepare

  WHEN THE METAL HEAD 6001-2810 IS PRESSED INTO DUAL MOBILE UH1-46-28 INTROPERATIVELY,HEAD CAN'T MOVE FREELY WITHOUT PUSHING WITH HAND HARD. CLUNK OCCURS WHEN MOVING. MAYBE THESE TWO MODELS CAN'T BE USED AND NEEDED CHANGING. EVENT UPDATE FROM (B)(6) 2018: SURGICAL DELAY IS NEARLY 1 HOUR. THE SURGEON SPENT NEARLY 20 MINUTES TO FIND ROOT CAUSE. AND THEN, THE SURGEON USED NEARLY 40 MINUTES TO CONFIRM THE FINAL REPLACEMENTS SIZE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8202357 ↗
• MalfunctionMay 8, 2018Mechanical Problem; Mechanical Problem

  IT IS REPORTED THAT A STRYKER HEAD WAS NOT SLIDING SMOOTHLY IN THE UHR BIPOLAR CUP.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 7493722 ↗