UHR UH1-43-26Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 07613327016864), received between Jun 18, 2018 and Dec 10, 2020 — classified as 1 death, 6 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (4 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.

• InjuryDec 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  AS REPORTED: "PATIENT HAD HIP FRACTURE SURGERY ON (B)(6) 2020. ON (B)(6) 2020, THE DOCTOR INFORMED ME THAT THE HEAD WAS DISLOCATED FROM THE TRUNNION OF THE STEM. THE DOCTOR PERFORMED HIP REVISION, REMOVED THE INITIAL HEAD FROM THE PATIENT, AND IMPLANTED ANOTHER HEAD AND BIPOLAR HEAD." SPOKE TO REP: THE HEAD AND BIPOLAR COMPONENT WERE REVISED BUT THERE ARE NO ALLEGATIONS AGAINST THE REVISED BIPOLAR COMPONENT. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Ambulation or Postural Difficulties; No Information

  MAUDE report 10987628 ↗
• InjurySep 3, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS CONVERTED FROM A HEMI TO A TOTAL HIP DUE TO PATIENT COMPLAINT OF PAIN. A BIPOLAR COMPONENT AND FEMORAL HEAD WERE REVISED TO A CERAMIC HEAD WITH SLEEVE AND COMPETITOR SHELL AND LINER. THE STEM WAS NOT REVISED. REP CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

  Patient problems: Injury; Pain

  MAUDE report 10487856 ↗
• InjuryJun 18, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  DR REPORTS PATIENT, A STATUS POST RIGHT BIPOLAR HIP DONE ON (B)(6) 2020 HAS HAD A POSTERIOR DISLOCATION AND REQUESTED TO REVISE TO A RESTORATION MODULAR WITH AN MDM CUP AND LINER. DR CAREFULLY REMOVED THE BIPOLAR COMPONENT WITH A BONE TAMP, THEN PROCEEDED TO REMOVE THE ACCOLADE II FEMORAL COMPONENT USING THE EXTRACTION DEVICE. ONCE REMOVED HE THEN PROCEEDED TO IMPLANT A NEW CUP MDM LINER AND A RESTORATION MODULAR HIP STEM. SATISFIED WITH THE STABILITY THE SURGICAL SITE WAS THEN CLOSED. THE SURGERY WAS PERFORMED WITHOUT INCIDENT. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Injury

  MAUDE report 10166966 ↗
• InjuryApr 10, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THE PATIENT'S LEFT HIP WAS REVISED DUE TO DISLOCATION. A 43MM UHR BIPOLAR COMPONENT AND 26 -3 LFIT HEAD WERE REVISED TO A 43MM UHR BIPOLAR COMPONENT AND A 26 +4 FEMORAL HEAD. REP CONFIRMED THERE ARE NO ALLEGATIONS AGAINST THE REVISED FEMORAL HEAD, AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED.

  Patient problems: Injury

  MAUDE report 9948333 ↗
• InjuryJun 24, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT'S LEFT HIP WAS REVISED DUE TO INFECTION (CONFIRMED CLINICALLY AS STREPTOCOCCUS). THE FEMORAL HEAD AND BIPOLAR COMPONENT WERE REVISED TO ANOTHER BIPOLAR COMPONENT AND FEMORAL HEAD.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 8728747 ↗
• DeathSep 12, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  ITS ALLEGED BY THE PATIENT'S SON, THROUGH THE FILLING OF A LEGAL CLAIM, THAT THE PATIENT UNDERWENT A RIGHT HIP HEMIARTHROPLASTY ON (B)(6) 2014. IT IS FURTHER ALLEGED THAT AFTER IMPLANTATION THE PATIENT EXPERIENCED PAIN, INFECTION, THYROID PROBLEMS, LEG LENGTH DISCREPANCY, WEIGHT GAIN, SKIN RASHES AND FATIGUE. PATIENT SUBSEQUENTLY DIED.

  Patient problems: Ambulation or Postural Difficulties; Death; Fatigue; Pain; Rash; Thyroid Problems; Unspecified Infection

  MAUDE report 7868355 ↗
• InjuryJun 18, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A STAGE 1 REVISION WAS PERFORMED ON PATIENT'S LEFT HIP DUE TO INFECTION. A BIPOLAR COMPONENT, RESTORATION MODULAR STEM SYSTEM, AND CABLE WERE REMOVED. AN ANTIBIOTIC SPACER WAS PUT IN.

  Patient problems: Injury; Unspecified Infection

  MAUDE report 7610756 ↗