Tandem 126648Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010079770), received between Jun 23, 2021 and Jun 23, 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

Recent adverse event reports

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

• InjuryJun 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT HAD A HEMI ARTHROPLASTY, AND DISLOCATED APPROX 9 DAYS AFTER SURGERY. A REVISION SURGERY WAS PERFORMED TO EXCHANGE THE TANDEM UNI 12/14 TPR SLV + 0 ((B)(4)) AND TANDEM UNIPOLAR 48MM ((B)(4)) FOR A BIPOLAR HEAD SIZE 47. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12053658 ↗

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.