Skip to content

Tandem 126654Recalls & reported problems

Smith & Nephew, Inc. · TANDEM UNIPOLAR HEAD 54MM · Class 2 · Implant

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 03596010079831), received between Dec 15, 2021 and Dec 15, 2021 — 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Unspecified Infection1

Recent adverse event reports

The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

  • InjuryDec 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON ((B)(6) 2021), DUE TO INFECTION A TWO STAGES REVISION SURGERY WAS PERFORMED. ON THE FIRST STAGE THE TANDEM UNIPOLAR HEAD 54MM (CASE (B)(4)), THE TANDEM UNIPOLAR 12/14 TAPER SLEEVE + 0 (CASE (B)(4)) AND THE SPECTRON EF 12/14 TAPER LONG STRAIGHT 225MM SMALL (CASE (B)(4)) WERE EXPLANTED AND A REVISION LONG STEM SPECTRON WITH A TANDEM UNIPOLAR HEAD, COATED IN ANTIBIOTIC CEMENT WERE PLACED INTO THE PATIENT. THE SECOND STAGE REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO EXTRACT THE DEVICES THAT WERE PUT IN ON THE FIRST STAGE SURGERY AND TO EXCHANGE THEM WITH THE IMPLANTS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

    Patient problems: Unspecified Infection

    MAUDE report 13012873 ↗

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, Classified
    Tandem 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

All Prosthesis, hip, hemi-, femoral, metal ball devices →

Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.