REDAPT 71354482Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556580769), received between Feb 16, 2019 and Jun 10, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (1 report).

1 other recall cover devices cleared under the same FDA submission (K151902, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJun 10, 2022Adverse 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) 2020, ON (B)(6) 2022 PATIENT UNDERWENT REVISION SURGERY DUE TO INFECTION, WHERE THE REDAPT 190MM SLEEVELESS REVISION STEM SIZE 15 HIGH OFFSET WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14655121 ↗
• InjuryFeb 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION. ALL IMPLANTS WERE REMOVED, AN ANTIBIOTIC SPACER WAS IMPLANTED INSTEAD.

  Patient problems: Unspecified Infection

  MAUDE report 8346414 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151902, 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.