TANDEM 71322049Recalls & reported problems
Smith & Nephew, Inc. · TANDEM BIPOLAR COBALT CHROME 49MM OUTER DIAMETER 28MM INNER DIAMETER · Class 2 · Implant
All models of TANDEM (58)
Data updated Oct 16, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 3
- Deaths reported
- 0
- Injuries reported
- 3
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 03596010492487), received between Nov 1, 2017 and Dec 14, 2023 — classified as 3 injuries.
The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).
3 other recalls cover devices cleared under the same FDA submission (K023743); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem2
- Insufficient Device Problem Information1
Patient problems
- Joint Dislocation2
- No Information1
Recent adverse event reports
The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.
InjuryDec 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT DISASSOCIATED FROM BIPOLAR HEAD. THE RING WAS INTACT, BUT THE FEMORAL HEAD POPPED OUT. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2023 TO ADDRESS THIS ADVERSE EVENT. THE SURGEON OPTED TO REMOVE THE FEMORAL HEAD AND REPLACE THE IMPLANT WITH A 49MM UNIPOLAR HEAD. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 18331188 ↗InjuryFeb 26, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
IT WAS REPORTED THAT, PATIENT HAD A HEMIARTHROPLASTY AND HAD TWO PREVIOUS DISLOCATIONS, DUE TO A THIRD DISLOCATION SURGEON DECIDED TO REMOVE THE COCR 12/14 FEM HEAD 28 +0 AND THE TANDEM BIPOLAR COCR 49OD 28ID AND PUT IN CUP AND LINER TO COVERT TO A TOTAL HIP. OUTCOME IS UNKNOWN.
Patient problems: Joint Dislocation
MAUDE report 11388912 ↗InjuryNov 1, 2017Insufficient Device Problem Information; Insufficient Device Problem Information
IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED TO REMOVE THE BIPOLAR SHELL.
Patient problems: No Information
MAUDE report 6994899 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K023743. 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.
- Z-0351-2017 · Aug 29, 2016 · TerminatedTANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 7132
- Z-0350-2017 · Aug 29, 2016 · TerminatedTANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051,
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 16, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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