UHR UH1-44-28Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07613327016895), received between Jul 3, 2018 and Oct 26, 2023 — classified as 8 injuries.

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 8 most recent of 8 reports, in the reporter's own words as published by the FDA.

• InjuryOct 26, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DISLOCATION OCCURRED AFTER BIPOLAR HEAD REPLACEMENT, AND REVISION TO THA WAS PERFORMED 2 WEEKS LATER.

  Patient problems: Joint Dislocation

  MAUDE report 18009586 ↗
• InjuryApr 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED. AS REPORTED: "THE REVISION TODAY WAS PERFORMED SECONDARY TO PAIN IN THE BIPOLAR HIP REPLACEMENT." AN ENTIRE HEMI HIP CONSTRUCT WAS CONVERTED TO A TOTAL HIP CONSTRUCT.

  Patient problems: Pain

  MAUDE report 16782260 ↗
• InjuryNov 1, 2022Detachment of Device or Device Component; Device Dislodged or Dislocated; Detachment of Device or Device Component; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S RIGHT HEMI HIP WAS REVISED. ORIGINALLY, THE BIPOLAR COMPONENT DISLOCATED FROM THE PATIENT'S NATIVE ACETABULUM. A CLOSED REDUCTION WAS ATTEMPTED, AND THE BIPOLAR COMPONENT DISSOCIATED FROM THE FEMORAL HEAD. THE BIPOLAR COMPONENT AND HEAD WERE REVISED.

  Patient problems: Joint Dislocation

  MAUDE report 15712732 ↗
• InjuryMay 18, 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. A BIPOLAR COMPONENT AND FEMORAL HEAD WERE REVISED TO A TOTAL HIP CONSTRUCT. AS REPORTED BY REP: "THE REVISION WAS DUE TO JOINT PAIN. NO OTHER INFORMATION AVAILABLE FROM THE DOCTOR OR HOSPITAL."

  Patient problems: Pain

  MAUDE report 14432681 ↗
• InjuryNov 10, 2021Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "THIS WAS A RIGHT SIDE HIP REVISION PERFORMED DUE TO PAINFUL BIPOLAR HIP. NO OTHER INFORMATION AVAILABLE FROM HOSPITAL." SPOKE TO REP: THE SURGEON DID NOT REPORT THE POSSIBLE CAUSE OR CONTRIBUTOR FOR THE PAIN. HIP WAS CONVERTED FROM BIPOLAR TO THA. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Pain

  MAUDE report 12791688 ↗
• InjuryJul 6, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT HAS BEEN REPORTED BY A LAWYER - "MY CLIENT, ON (B)(6) 2016, WAS SUBMITTED FOR SURGERY OF RIGHT HIP ARTHROPLASTY AND PROSTHESIS IMPLANTED AS FOLLOWS: STYKER V40TM FEMORAL HEAD - OD 28MM - OFFSR 0MM - REF 6260-5-128 - LOT 56124001; ABGTM II FEMORAL STEM - RIGHT - SZE # 3 - SDE RT¿ - TPR V40TM - REF 4845-0103 - LOT G5531395A; UHR UNIVERSAL HEAD BIPOLAR COMPONENT - OD 44 MM - ID 28MM - REF UH1-44-28 - LOT T55JYH; MY CLIENT, RIGHT FROM HER APPLICATION, ACCUSED ENORMOUS DISCOMFORT AND MOBILITY PROBLEMS WHICH, BY HERSELF AND BY THE DOCTORS CONSULTED, WERE LINKED TO THE NORMAL PERIOD OF ABSORPTION AND ADAPTATION TO THE AFOREMENTIONED PROSTHESIS; ON (B)(6) 2017, JUST OVER A YEAR LATER, MY CLIENT WAS FORCED TO HOSPITALIZE AGAIN WITH THE FOLLOWING DIAGNOSIS: "COTYLOIDITIS IN RESULTS OF HIP ENDOPROTESIS"; THEREFORE, ON (B)(6) 2017, MY CLIENT UNDERWENT A NEW SURGERY OF "COTILE DX REPLACEMENT"; "...AFTER JUST OVER A YEAR TO AN INTERVENTION OF REPLACEMENT OF THE CUP OF THE ARTHROPLASTY IMPLANTED IN MY CLIENT..."

  Patient problems: Pain

  MAUDE report 12123832 ↗
• InjuryDec 18, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6) 2020, DR (B)(6) I+D OF RIGHT HIP, PRE OP DX INFECTED RIGHT TOTAL HIP. ORIGINAL IMPLANT DATE: (B)(6) 2020, DR . REMOVED 44' BIPOLAR HEAD AND 28+ METAL HEAD. NO INFORMATION AS PER HOSPITAL, EXPLANTS NOT AVAILABLE FOR RETURN, SAME SIZE COMPONENTS RE-IMPLANTED.

  Patient problems: Unspecified Infection

  MAUDE report 11035781 ↗
• InjuryJul 3, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENTS' RIGHT HIP WAS REVISED DUE TO GROIN PAIN. PATIENT'S CARTILAGE WAS REPORTED WORN OUT, OTHERWISE NO DEVICES WERE OBSERVED TO BE LOOSE OR BROKEN. PATIENT WAS REVISED TO A TRIDENT II CONSTRUCT.

  Patient problems: Erosion; Injury; Pain

  MAUDE report 7658613 ↗