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TANDEM 71322053Recalls & reported problems

Smith & Nephew, Inc. · TANDEM BIPOLAR COBALT CHROME 53MM 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
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 03596010492524), received between May 31, 2022 and May 31, 2022 — classified as 1 injury.

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.

Most reported problems

Device problems

  • Adverse Event Without Identified Device or Use Problem1

Patient problems

  • Joint Laxity1
  • Unspecified Infection1

Recent adverse event reports

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

  • InjuryMay 31, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    IT WAS REPORTED THAT, AFTER A HEMI-ARTHROPLASTY WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED HIP INSTABILITY. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2022 TO REVISE TO TOTAL; HOWEVER, DURING THE SURGERY IT WAS FOUND THAT THE SYN CEM FEM COMP SZ 14 WAS LOOSE AND PULLED OUT WITH EASE. ALSO, IT WAS FOUND THAT THERE WAS A POSSIBLE PATIENT INFECTION, AND THAT NO BONE CEMENT WAS BONDED TO STEM. THEREFORE, THE TANDEM BIPOLAR COCR 53OD 28ID, THE INVIS DIST CENT SZ 11MM AND THE OXINIUM FEM HD 12/14 28MM +0 WERE EXPLANTED ALONG WITH THE STEM. THE PATIENT IS CURRENTLY ON THE FIRST STAGE OF A TWO-STAGES REVISION SURGERY, FOR WHICH A CEMENT SPACER IS BEING USED. NO FURTHER INFORMATION IS AVAILABLE.

    Patient problems: Joint Laxity; Unspecified Infection

    MAUDE report 14545521 ↗

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, 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.
  • Z-0350-2017 · Aug 29, 2016 · Terminated
    TANDEM (TM) COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71322040, 71322041, 71322042, 71322043, 71322044, 71322045, 71322046, 71322047, 71322048, 71322049, 71322050, 71322051,
  • Z-0351-2017 · Aug 29, 2016 · Terminated
    TANDEM (TM) INTL COCR SHELL UHMWPE LINER BIPOLAR, REF NUMBERS: 71324038, 71324039, 71324040, 71324041, 71324042, 71324043, 71324044, 71324045, 71324046, 71324047, 71324048, 7132

Other Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices

All Prosthesis, hip, hemi-, femoral, metal/polymer, cemented or uncemented devices →

Sources and updates

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