REDAPT 71354855Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556580394), received between Sep 27, 2021 and Sep 27, 2021 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K162303, 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 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.

• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2018, THE PATIENT PRESENTED TO HOSPITAL WITH A SIGNIFICANT INFECTION AND AN ABSCESS OF HIS RIGHT HIP EXTENDING DISTALLY TO APPROXIMATELY 10CM PROXIMAL TO THE KNEE. THIS ADVERSE SITUATION WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2021, WHERE THE REDAPT 300MM SLEEVED REVISION STEM SIZE 13 HIGH OFFSET, THE REDAPT MODULAR SLEEVE MEDIUM SIZE 12-13 STIKTITE WITH HYDROXYAPATITE AND THE BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8 WERE REMOVED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12537679 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162303, 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.