NA 71302204Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010194046), received between Mar 6, 2019 and Mar 6, 2019 — classified as 1 injury.

The most frequently reported specific device problem is “Physical Resistance/Sticking” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K963509); 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 18, 2026.

Most reported problems

Recent adverse event reports

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

• InjuryMar 6, 2019Physical Resistance/Sticking; Physical Resistance/Sticking

  DR (B)(6) PERFORMED A HEMIARTHROPLASTY ON HIS PATIENT USING THE ABOVE IMPLANTS. ONCE THE HIP WAS REDUCED HE NOTED THAT THERE WAS NO MOVEMENT BETWEEN THE 22MM FEMORAL HEAD AND THE TANDEM SHELL, EFFECTIVELY NEGATING THE BENEFIT OF USING A BI-POLAR CONSTRUCT. EVEN ON MOVING THE ARTICULATING SURFACE BY HAND THE COMPONENTS WERE VERY STIFF AND RESISTANT TO FREE MOVEMENT. REVISION SURGERY WAS PERFORMED ON (B)(6) 2018.

  Patient problems: Injury

  MAUDE report 8394763 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K963509. 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.