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UHR UH1-41-26Recalls & reported problems

Howmedica Osteonics Corp. · Bipolar Component · Class 2 · Implant

1 open recall names this device. See the recall details and contact the manufacturer or your healthcare provider.

Adverse event reports
1
Deaths reported
0
Injuries reported
1
Recalls naming it
1

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07613327016802), received between Feb 24, 2021 and Feb 24, 2021 — 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. How this data works · Data updated Oct 13, 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 · FDA record ↗

Most reported problems

Device problems

  • Device Dislodged or Dislocated1

Patient problems

  • Joint Dislocation1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryFeb 24, 2021Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT THE PATIENT'S RIGHT HIP WAS REVISED. AS REPORTED BY REP: "RIGHT HIP OPEN REDUCTION, I&D, POSSIBLE REVISION TO DUAL MOBILITY OR CONSTRAINED HIP REPLACEMENT, POSSIBLE RESECTIONAL ARTHROPLASTY, AND CEMENT SPACER. PRE-OP DIAGNOSIS: RIGHT HIP DISLOCATION AND POSSIBLE INFECTION, STATUS POST BIPOLAR HEMIARTHROPLASTY. REMOVED ALL COMPONENTS." AN ACCOLADE II STEM, V40 METAL HEAD, AND BIPOLAR COMPONENT WERE REVISED. REP PROVIDED OPERATIVE REPORTS FOR PRIMARY AND (B)(6) 2020 REVISION, X-RAYS PRIOR TO (B)(6) 2021 REVISION, AND USAGE SHEET FROM (B)(6) 2020 REVISION AND CONFIRMED THAT NO FURTHER INFORMATION WILL BE RELEASED BY THE HOSPITAL OR SURGEON.

    Patient problems: Joint Dislocation; Unspecified Infection

    MAUDE report 11372221 ↗

Other Prosthesis, hip, hemi-, femoral, metal devices

All Prosthesis, hip, hemi-, femoral, metal devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.