Tandem 126645Recalls & reported problems
Smith & Nephew, Inc. · TANDEM UNIPOLAR HEAD 45MM · Class 2 · Implant
All models of TANDEM (58)
Data updated Oct 16, 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 03596010079749), received between May 5, 2020 and May 5, 2020 — classified as 1 injury.
1 other recall cover devices cleared under the same FDA submission (K211176, K231448, K896580); 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 16, 2026.
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Joint Dislocation1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjuryMay 5, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A HIP HEMIARTHROPLASTY, THE PATIENT SUFFERED A DISLOCATION. A REVISION SURGERY WAS PERFORMED TO TREAT THE EVENT: THE TANDEM UNIPOLAR HEAD WAS EXPLANTED AND REPLACED WITH A OR3O IMPLANT. THE PATIENT OUTCOME IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 10026285 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K211176, K231448, K896580. 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 ball devices
- NA 1363-10-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball117 reports
- NA 1363-08-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball66 reports
- NA 1363-12-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball44 reports
- NA 1363-46-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball39 reports
- NA 1363-47-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball34 reports
- NA 1363-45-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball31 reports
- NA 1363-44-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball25 reports
- NA 1363-49-000Depuy Orthopaedics, Inc. · Prosthesis, hip, hemi-, femoral, metal ball23 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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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