BIRMINGHAM HIP 74121642Recalls & reported problems
Smith & Nephew, Inc. · 42/28MM 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
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556577202), received between Oct 9, 2021 and Oct 9, 2021 — classified as 1 injury.
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.
Most reported problems
Device problems
- Degraded1
Patient problems
- Failure of Implant1
- Loss of Range of Motion1
- Metal Related Pathology1
- Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryOct 9, 2021Degraded; Degraded
US LEGAL MDL. IT WAS REPORTED THAT A SECOND REVISION SURGERY WAS PERFORMED ON THE PATIENT RIGHT HIP ON (B)(6) 2020. THE SECOND REVISION WAS PERFORMED DUE TO ELEVATED SERUM COBALT AND CHROMIUM LEVELS, METALLOSIS, MECHANICAL FAILURE OF MODULAR DUAL MOBILITY CONSTRUCT, PROXIMAL FEMORAL MIGRATION, LINER WEAR, PAIN, DECREASED MOBILITY AND PSEUDOTUMOR FORMATION. DURING THIS PROCEDURE, THE ACETABULAR CUP, XLPE LINER, AND OXINIUM FEMORAL HEAD WERE EXPLANTED, AND A DEBRIDEMENT OF METALLOSIS AND ALLOGRAFT AUGMENTATION ON THE ACETABULUM WERE CONDUCTED. THE PATIENT WAS TAKEN TO THE RECOVERY ROOM, EXTUBATED AND IN STABLE CONDITION.
Patient problems: Failure of Implant; Loss of Range of Motion; Metal Related Pathology; Pain
MAUDE report 12602019 ↗
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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