UHR UH1-47-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327016970), received between May 29, 2019 and May 19, 2026 — classified as 4 injuries, 3 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 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.

• InjuryMay 19, 2026Fracture

  THE FOLLOWING INFORMATION WAS PROVIDED: REMOVAL OF BIPOLAR UHR AND INNER HEAD AND REVISION TO CEMENTED CUP/CAGE. REMOVAL OF H-GRIP AND DALL MILES CABLES , 1X CABLE BROKEN. NOTIFICATION ONLY.

  Patient problems: Insufficient Information

  MAUDE report 25214164 ↗
• InjuryFeb 6, 2025Device Dislodged or Dislocated; Device Dislodged or Dislocated

  THA WAS PERFORMED ABOUT 2 MONTHS AGO. TWO MONTHS AFTER SURGERY, THE PATIENT DISLOCATED HIP. THE CUP WAS DISLODGED DURING MANUAL REPOSITIONING. LATER, THE CUP WAS REPLACED. THE HEAD WAS ALSO REPLACED AND THE NECK LENGTH WAS EXTENDED.

  Patient problems: Joint Dislocation

  MAUDE report 21321724 ↗
• InjuryJul 13, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  LEFT HIP REVISION - HEMIARTHROSCOPY TO TOTAL HIP REPLACEMENT DUE TO RECURRENT DISLOCATIONS. REMOVED BIPOLAR HEAD AND REPLACED WITH MDM + TRITANIUM HEMISPHERICAL CUP. RECURRENT DISLOCATIONS SINCE INITIAL HEMIARTHROSCOPY ON (B)(6) 2023 - REVISED TO TOTAL HIP ON (B)(6) 2023.

  Patient problems: Joint Dislocation

  MAUDE report 17322280 ↗
• InjuryJun 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  LEFT HIP HEMI ARTHROPLASTY. THE REVISION TODAY WAS SECONDARY TO INFECTION. NO FURTHER INFORMATION IS AVAILABLE FROM SURGEON OR HOSPITAL.

  Patient problems: Unspecified Infection

  MAUDE report 17103044 ↗
• MalfunctionAug 29, 2019Device Difficult to Setup or Prepare; Fitting Problem; Device Difficult to Setup or Prepare; Fitting Problem

  PRIMARY PROCEDURE, RIGHT HIP. IT WAS REPORTED THAT AFTER ASSEMBLY, THE 28 -4 BIOLOX HEAD WOULD NOT ARTICULATE FREELY WITH THE UHR BIPOLAR COMPONENT. THE DEVICES WERE WASTED AND A 28 -4 LFIT HEAD WITH A COMPETITOR BIPOLAR COMPONENT WAS USED TO COMPLETE THE SURGERY SUCCESSFULLY WITH A SURGICAL DELAY OF APPROXIMATELY 10 MINUTES. A USAGE SHEET SHOWING THE WASTED IMPLANTS WAS SUPPLIED, AND THE DEVICES ARE AVAILABLE FOR RETURN, BUT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient; No Known Impact Or Consequence To Patient

  MAUDE report 8946999 ↗
• MalfunctionJul 30, 2019Device Damaged Prior to Use; Device Damaged Prior to Use

  DURING THE SURGERY, THE DOCTOR NOTICED THAT TWO ITEMS WERE DEFECTIVE. ADDITIONAL INFORMATION: DURING THE SURGERY, THE OPERATOR STATED THAT THE HEAD THAT WAS SLAMMED IN THE HEAD OF UH1 WEAKLY MOVES AND WILL CAUSE DISLOCATION IN THE JOINT, HE DECIDED TO CHANGE THE HEAD AND HEAD OF UH1.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8841783 ↗
• MalfunctionMay 29, 2019Device Contaminated During Manufacture or Shipping; Device Contaminated During Manufacture or Shipping

  UHR HEAD CONTAMINATED WITH BLUE AND BLACK STUFF. DURING SURGERY 2-3 MIN DELAY TO GET A NEW ONE FROM SHELF.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8649359 ↗