Tandem 126643Recalls & reported problems
Smith & Nephew, Inc. · TANDEM UNIPOLAR HEAD 43MM · Class 2 · Implant
Data updated Oct 13, 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 03596010079725), received between May 5, 2022 and Nov 15, 2023 — classified as 2 injuries.
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. How this data works · Data updated Oct 13, 2026.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
Patient problems
- Arthralgia1
- Joint Dislocation1
Recent adverse event reports
The 2 most recent of 2 reports, in the reporter's own words as published by the FDA.
InjuryNov 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER UNDERGOING HIP HEMIARTHROPLASTY ON (B)(6) 2023, THE PATIENT PRESENTED PAIN IN THE ACETABULUM. IT WAS STATED THAT PAIN WAS EXPERIENCED DUE TO ACTIVITY AND NOT BECAUSE OF ANY IMPLANT MALFUNCTION. THIS EVENT WAS TREATED WITH A CONVERSION TO TOTAL HIP ARTHROPLASTY ON (B)(6) 2023, IN WHICH THE 43MM TANDEM UNIPOLAR HEAD WAS REMOVED AND THE PRIMARY FEMORAL STEM REMAINED IN SITU. PATIENT¿S CURRENT HEALTH STATUS IS UNKNOWN.
Patient problems: Arthralgia
MAUDE report 18139589 ↗InjuryMay 5, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED DISLOCATION. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2022 TO EXPLANT THE TANDEM UNIPOLAR 43MM. A BIPOLAR WITH A SOFT TISSUE REPAIR WAS INSERTED. THIS EXCHANGE FIXED THE DISLOCATION PROBLEM. IT IS UNKNOWN THE CURRENT HEALTH STATUS OF THE PATIENT.
Patient problems: Joint Dislocation
MAUDE report 14288299 ↗
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 1363-48-000Depuy 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 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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