REDAPT 71354233Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556321393), received between Apr 22, 2024 and Apr 22, 2024 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K150790, K181366, K211176); 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.

• InjuryApr 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY ON THE PATIENT'S RIGHT HIP ON (B)(6) 2021 DUE TO AN ACETABULAR COLUMN FRACTURE , PATIENT EXPERIENCED AN INFECTION THAT REQUIRED REVISION SURGERY WITH IRRIGATION AND DEBRIDEMENT ON (B)(6) 2021. ALL DEVICES WERE EXPLANTED AND EXCHANGED FOR A POROUS SHELL AND POLARCUP LINER. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 19160324 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K150790, K181366, K211176. 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.