UHR UH1-46-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07613327016949), received between Mar 27, 2017 and Nov 15, 2023 — classified as 11 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (5 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 16, 2026.

Recalls naming this device

1. Jul 30, 2026Open, 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryNov 15, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IN REPORTING A REVISION OF THE PATIENT'S RIGHT HIP ON (B)(6) 2023, REP REPORTED THAT THE PRIOR SURGERY WAS ALSO A REVISION OF A HEMI HIP DUE TO DISLOCATION. A 46MM BIPOLAR COMPONENT AND 26 +0 FEMORAL HEAD WERE REVISED TO A 48MM BIPOLAR HEAD AND 26 +4 FEMORAL HEAD. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Joint Dislocation

  MAUDE report 18137983 ↗
• InjuryJan 16, 2023Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION OF THE UHR BIPOLAR COMPONENT FROM THE PATIENT'S NATIVE ACETABULUM. THE BIPOLAR COMPONENT AND FEMORAL HEAD WERE REMOVED AND THE PATIENT WAS CONVERTED TO A TOTAL HIP WITH CONSTRAINED LINER. REP CONFIRMED THAT THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD.

  Patient problems: Joint Dislocation

  MAUDE report 16173672 ↗
• InjuryJan 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR. REVISED A LEFT BIPOLAR HIP DONE ORIGINALLY IN THE 1980'S DUE TO DISASSOCIATION. HE REVISED TO A COMPETITOR CUP/LINER AND STRYKER MORSE TAPER HEAD. REP PROVIDED X-RAYS AND REPORTED THAT NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9566477 ↗
• InjuryFeb 4, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO PAIN. NO POSSIBLE CAUSE OR CONTRIBUTOR TO PAIN WAS REPORTED TO THE REP, AND NOTHING WAS FOUND LOOSE OR BROKEN INTRA-OPERATIVELY. REP REPORTED THAT NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 8302364 ↗
• InjuryDec 7, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT PATIENT'S LEFT HIP WAS REVISED.

  Patient problems: Injury

  MAUDE report 8141830 ↗
• InjuryJul 16, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  DR. (B)(6) REMOVED A BIPOLAR PROSTHESIS AND IMPLANTED A CUP/LINER AND NEW HEAD. PATIENT PRESENTED WITH PAIN IN HER RIGHT HIP.

  Patient problems: Injury; Pain

  MAUDE report 7689841 ↗
• InjuryJun 25, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT PATIENT'S RIGHT HIP WAS REVISED DUE TO A DISLOCATION AFTER PATIENT SUFFERED A FALL. AN LFIT COCR HEAD AND UHR BIPOLAR COMPONENT WERE REVISED TO A HIGHER-DIAMETER STRYKER LFIT HEAD WITH COMPETITOR SHELL AND LINER. A REVIEW BY A CLINICAL CONSULTANT INDICATED: XRAYS REVIEWED DEMONSTRATE THE PATIENT SUFFERED A PERIPROSTHETIC POSTERIOR ACETABULAR WALL FRACTURE WITH SUBLUXATION OF THE BIPOLAR COMPONENT.

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

  MAUDE report 7635596 ↗
• InjuryMay 17, 2018Loss of Osseointegration; Device Dislodged or Dislocated; Loss of Osseointegration; Device Dislodged or Dislocated

  PHYSICIAN EXPLANTED A BIPOLAR HIP (STEM AND HEAD) DUE TO DISLOCATION. HE SAID THE REASON FOR DISLOCATION WAS THE ACETABULUM DIDN'T HAVE MUCH POSTERIORLY TO CAPTURE THE HEAD. HE SAID THERE WASN'T MUCH ACETABULUM TO WORK WITH, SO HE DECIDED NOT TO DO A TOTAL HIP. HE SAID THE PATIENT DOESN'T WALK ANYWAY. THE ORIGINAL DATE OF SURGERY WAS (B)(6) 2018.

  Patient problems: Inadequate Osseointegration; Injury; Joint Dislocation

  MAUDE report 7522926 ↗
• InjuryDec 21, 2017Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THROUGH THE SUBMISSION OF A REVISION IMPLANT SHEET THAT THE PATIENT'S RIGHT HIP WAS REVISED. REP REPORTED THAT PATIENT WAS NON-COMPLIANT AFTER A HEMI HIP ARTHROPLASTY, FELL OUT OF HER BED, DISLOCATED (HEAD FROM BIPOLAR COMPONENT) AND SUFFERED A FRACTURED ACETABULUM. SURGEON CONVERTED THE PATIENT TO A TOTAL HIP.

  Patient problems: Bone Fracture(s); Fall; Injury

  MAUDE report 7139826 ↗
• InjuryDec 11, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  AS REPORTED: "PATIENT'S RIGHT HIP REVISED DUE TO BIPOLAR CONSTRUCT DISLOCATING. SURGEON SAID HE SUSPECTS WEAK ABDUCTORS SO HE CONVERTED THE CONSTRUCT TO A TOTAL HIP WITH CONSTRAINED LINER."

  Patient problems: Injury

  MAUDE report 7104742 ↗
• InjuryMar 27, 2017Loose or Intermittent Connection; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE OUTER HEAD (46/26) OF A BIPOLAR HEMI HIP DISENGAGED FROM THE INNER HEAD (26/+0). THE SURGEON IS CONFIDENT THAT SHE DID NOT IMPACT THE OUTER HEAD ONTO THE INNER HEAD WITH ENOUGH FORCE DURING THE FIRST SURGERY DUE TO PATIENT'S POOR BONE QUALITY. SURGEON DOES NOT BELIEVE IT IS A PRODUCT ISSUE, HOWEVER A PER IS STILL REQUIRED.

  Patient problems: Injury; Joint Dislocation; No Known Impact Or Consequence To Patient

  MAUDE report 6436033 ↗