NA 71302812Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010194152), received between Nov 16, 2021 and Nov 16, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Break” (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.

• InjuryNov 16, 2021Break; Connection Problem; Break; Connection Problem

  IT WAS REPORTED THAT DURING A THR THE HEAD OF A COBALT CHROME 12/14 FEM HEAD 28 + 12 DID NOT WELD OR LOCK ONTO STEMS. THE PROCEDURE WAS COMPLETED WITH A BACKUP DEVICE AND WITH NO DELAYS. NO INJURIES WERE REPORTED. ON VISUAL INSPECTION IT WAS FOUND THAT INSIDE THE DEVICE THE WELD POINT IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12820735 ↗

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.