UHR UH1-42-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327016857), received between Sep 5, 2019 and Sep 5, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 5, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  PATIENT'S CONSTRAINED ACETABULAR LINER, WHICH WAS IMPLANTED ON (B)(6) 2019, BECAME DISENGAGED. RESULTING IN A HIP DISLOCATION. ON FRIDAY AUG 9, THE PATIENT HAD REVISION HIP SURGERY TO CORRECT. THE SURGEON REPLACED THE BROKEN LINER WITH ANOTHER CONSTRAINED LINER. UPDATE 12/AUGUST/2019 WG: REP CALLED IN RESPONSE TO FIRST REQUEST FOR ADDITIONAL INFORMATION. THERE WAS NO SURGICAL DELAY. PATIENT HISTORY: PRIMARY REPLACEMENT OF COMPETITOR DEVICES, 2-STAGE REVISION IN WHICH THE SECOND STAGE HAD STRYKER DEVICES IMPLANTED, THEN THIS REVISION. REP CONFIRMED THE INNER BIPOLAR HEAD CAME OUT OF THE OUTER LINER. THE FEMORAL HEAD WAS STILL IN THE INNER BIPOLAR HEAD. REP PROVIDED X-RAYS AND CONFIRMED THE DEVICE IS AVAILABLE FOR RETURN, AND REPORTED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 8964913 ↗