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TANDEM 71324049Recalls & reported problems

Smith & Nephew, Inc. · TANDEM INTERNATIONAL BIPOLAR 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
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 03596010494405), received between Mar 11, 2018 and Mar 11, 2018 — classified as 1 injury.

3 other recalls cover devices cleared under the same FDA submission (K023743, K211176, K231448); 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

  • Injury1
  • Pain1

Recent adverse event reports

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

  • InjuryMar 11, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

    UNEXPLAINED PAIN IN LATERAL TROCHANTERIC REGION. POSSIBLY ASSOCIATED WITH A SIGNIFICANT LOSS OF OFFSET IN THE JOINT POST PRIMARY SURGERY. SURGEON BEGAN DISSECTING DOWN TO HIP JOINT. ON APPROACH TO THE HIP JOINT A TROCHANTERIC SOFT TISSUE MASS WAS IDENTIFIED. ACCORDING TO SURGEON IS WAS PROBABLY CALCIFIC TENDONOPATHY ASSOCIATED WITH LOSS OF FUNCTION AS RESULT OF THE REDUCED OFFSET IN THE HIP AFTER THE PRIMARY SURGERY. THE AREA WAS EXTREMELY INFLAMED WITH SOME MINOR BLEEDING OVER AND AROUND THE SITE. THE CALCIFICATION DEPOSIT WAS DEBRIDED. HIP JOINT OPENED. DISLOCATED HIP. TAPPED OFF BIPOLAR HEAD WITH BONE PUNCH. REMOVED CEMENT FROM AROUND SHOULDER OF THE STEM. STEM REMOVED WITH RENOVATION SLAP HAMMER. MANTLE WITHIN CANAL ASSESSED AND DEEMED APPROPRIATE FOR CEMENT IN CEMENT REVISION OF STEM. ACETABULUM PREPARED FOR CORIN TRINITY SHELL. SHELL IMPACTED AND LINER INSERTED. SIZE 1 HIGH OFFSET STEM CEMENTED INTO EXISTING MANTLE WITHIN PROXIMAL FEMUR. CONSTRUCT TRIALLED AND DEEMED STABLE. DEFINITIVE HEAD IMPLANTED INTO THE STEM. HIP REDUCED. WOUND CLOSED.

    Patient problems: Injury; Pain

    MAUDE report 7329701 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K023743, K211176, K231448. 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

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Sources and updates

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