UHR UH1-48-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327017007), received between Feb 2, 2017 and Nov 16, 2023 — classified as 7 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. 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.

• InjuryNov 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "DISLOCATED BIPOLAR HIP. REVISED TO CUP AND LINER AND NEW HEAD." REP CONFIRMED NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 18146373 ↗
• InjuryJul 25, 2023Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED: "PATIENT WOUND DEHISCED, HAD A HEMATOMA. WASHED OUT AND CHANGED THE 26MM HEAD AND BIPOLAR HEAD. WENT TO +4 LENGTH."

  Patient problems: Hematoma; Wound Dehiscence

  MAUDE report 17393301 ↗
• InjuryJul 1, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED BY REP: "INFECTED HEMI HIP (LEFT SIDE). REMOVED IMPLANTS. PLACED STATIC SPACER".

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8748956 ↗
• InjuryFeb 18, 2019Migration; Migration

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED. PATIENT FELL AND BROKE HER PELVIS, CREATING A PELVIC DISCONTINUITY THAT ALLOWED THE BIPOLAR HEAD TO PASS THROUGH THE MEDIAL WALL OF THE ACETABULUM. THE 48X26 BIPOLAR COMPONENT AND 26 +0 LFIT HEAD WERE REVISED TO A TOTAL HIP CONSTRUCT WITH A GAP SHELL, SCREWS, POLY LINER, AND 36 METAL HEAD. THE STEM WAS WELL FIXED, WELL POSITIONED, AND NOT REVISED.

  Patient problems: Fall; Injury

  MAUDE report 8347681 ↗
• InjuryDec 19, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED BECAUSE OF THE DISLOCATION OF THE BIPOLAR COMPONENT FROM THE PATIENT'S ACETABULUM. THE BIPOLAR COMPONENT AND FEMORAL HEAD WERE REVISED USING A COMPETITOR SHELL AND LINER WITH A 32+0 LFIT V40 HEAD.

  Patient problems: Injury

  MAUDE report 8182705 ↗
• InjuryOct 9, 2018Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT PATIENT'S LEFT HIP WAS REVISED APPROXIMATELY 1 MONTH POST-OP DUE TO RECURRENT DISLOCATIONS. A STRYKER BIPOLAR COMPONENT AND FEMORAL HEAD AS PART OF A HEMI HIP CONSTRUCT WERE REVISED TO A TOTAL HIP WITH COMPETITOR ACETABULAR COMPONENTS AND ANOTHER STRYKER HEAD. THE OTHER FEMORAL COMPONENTS WERE NOT REVISED. REP REPORTED THAT X-RAYS, MEDICAL RECORDS, AND ADDITIONAL INFORMATION ARE NOT AVAILABLE DUE TO HOSPITAL POLICY. UPDATE: SURGEON REPORTED CAUSE OF DISLOCATION WAS DUE TO A POSTERIOR ACETABULAR RIM FRACTURE (NO TRAUMA REPORTED TO REP). SURGEON ALSO REPORTED THAT "COMPONENT PLACEMENT WAS EXCELLENT".

  Patient problems: Bone Fracture(s); Injury; Joint Dislocation

  MAUDE report 7947125 ↗
• InjuryFeb 2, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT WAS REVISED FOR INFECTED LEFT BIPOLAR HIP. PATIENT WAS BROUGHT TO OR FOR I&D OF LEFT HIP WITH REPLACEMENT OF FEMORAL HEAD AND UHR BIPOLAR COMPONENT.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 6298179 ↗