BIRMINGHAM HIP 74121654Recalls & reported problems
Smith & Nephew, Inc. · 54/28MM 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
- 2
- Deaths reported
- 0
- Injuries reported
- 2
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556577264), received between Jul 14, 2020 and Feb 8, 2026 — classified as 2 injuries.
The most frequently reported specific device problem is “Degraded” (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.
Reports received per month
Most reported problems
Device problems
- Degraded1
- Patient Device Interaction Problem1
- Unintended Movement1
Patient problems
- Injury1
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryFeb 8, 2026Degraded
IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED IN (B)(6) 2022, THE PATIENT FELT SOME CLUNKING IN (B)(6) 2025, AND WHILE PLAYING PICKLEBALL IN (B)(6) 2026, HE FELT A BIG CLUNK. X-RAY REVEALED WHAT APPEARED TO BE A DISSOCIATED 54/28MM BH DUAL MOBILITY INSERT. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6) 2026, IN WHICH THE 54/28MM BH DUAL MOBILITY INSERT, THE OXINIUM FEM HD 12/14 28MM +0, AND THE ACETLR CUP HAP 60MM W/ IMPTR WERE EXPLANTED. FURTHER INSPECTION SHOWED THE 54/28MM BH DUAL MOBILITY INSERT WAS HEAVILY WORN. THE CURRENT HEALTH STATUS OF PATIENT IS GOOD.
Patient problems: Joint Dislocation
MAUDE report 24288370 ↗InjuryJul 14, 2020Unintended Movement; Patient Device Interaction Problem; Unintended Movement; Patient Device Interaction Problem
IT WAS REPORTED THAT THE PATIENT UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION ON (B)(6) 2019. THE CUP WAS RETAINED AND THE UNKNOWN CERAMIC HEAD WAS INVOLVED. THE STEM WAS FROM A COMPETITOR DEVICE.
Patient problems: Injury
MAUDE report 10269948 ↗
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, ClassifiedTandem 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
- STAGEONE 431209Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented2 recalls0 reports
- SELF CENTERING 1035-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented84 reports
- LFIT 6260-9-036Howmedica Osteonics Corp. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented80 reports
- ACTIS 101011060Depuy (Ireland) · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented66 reports
- RINGLOC BI-POLAR HIP SYSTEM 11-165228Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall1 death12 reports
- SELF CENTERING 1035-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented60 reports
- TANDEM 71324046Smith & Nephew, Inc. · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented1 recall9 reports
- TAPERLOC COMPLETE XR 123 MICRO FEMORAL 51-145170Biomet Orthopedics, LLC · Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented59 reports
Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 14, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 16, 2026
- Page last rebuilt: Oct 18, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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