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BIRMINGHAM HIP 74121650Recalls & reported problems

Smith & Nephew, Inc. · 50/28MM BH DUAL MOBILITY INSERT · Class 2 · Implant

All models of BIRMINGHAM HIP (16)

Data updated Oct 18, 2026 from official FDA records · Editorial policy

Adverse event reports
3
Deaths reported
0
Injuries reported
2
Recalls naming it
0

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556577240), received between Nov 3, 2020 and Sep 12, 2022 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K171934, K211176); they may or may not involve this specific model.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1
  • Appropriate Device Problem Term/Code Not Available1
  • Device Dislodged or Dislocated1

Patient problems

  • Failure of Implant1
  • Joint Dislocation1
  • Unspecified Infection1

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

  • MalfunctionSep 12, 2022Device Dislodged or Dislocated; Device Dislodged or Dislocated

    IT WAS REPORTED THAT, AFTER A THR, A OXNM FEM HD 28 MM +12 DISASSOCIATED FROM A 50/28 MM BH DUAL MOBILITY INSERT. PATIENT WALKED ON IT FOR SOME TIME BEFORE SEEKING MEDICAL ATTENTION. CUP WAS REVISED AND A NEW FEMORAL HEAD IMPLANTED. ECHELON STEM WAS WELL FIXED AND REMAINED. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH A COMPETITOR BACK-UP DEVICE INSTEAD. NO OTHER COMPLICATIONS WERE REPORTED.

    Patient problems: Joint Dislocation

    MAUDE report 15407853 ↗
  • InjuryFeb 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT A REVISION OF A TOTAL RIGHT HIP WAS PERFORMED. A SMITH & NEPHEW UNIPOLAR HEAD AND INSERT WERE EXPLANTED. SMITH & NEPHEW SYNERGY FEMORAL STEM AND BHR CUP REMAINED IN PLACE.

    Patient problems: Failure of Implant

    MAUDE report 11371667 ↗
  • InjuryNov 3, 2020Appropriate Device Problem Term/Code Not Available

    IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO POST OPERATIVE INFECTION. DURING THIS REVISION SURGERY NO IMPLANTS WERE EXPLANTED, A CENTRAL VENOUS CATH PLACEMENT WITH GUIDANCE WAS PERFORMED.

    Patient problems: Unspecified Infection

    MAUDE report 10778721 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K171934, K211176. One submission often covers many models, so check the product and lot details in each record.

  • Z-0326-2025 · Oct 15, 2024 · Open, Classified
    Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

Sources and updates

How reports and recalls are matched · Editorial policy · Report an error on this page