REDAPT 71354707Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556579329), received between Sep 24, 2021 and Sep 24, 2021 — classified as 1 injury.

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. 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.

• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AS PART OF AN UNSPECIFIED MEDICAL INDICATION, A PATIENT UNDERWENT A THR REVISION SURGERY ON THE RIGHT HIP ON (B)(6) 2017. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 240MM SZ 18 SO WAS IMPLANTED. 10 MONTHS POSTOPERATIVELY, THE PATIENT EXPERIENCED OCCLUSION OF THE FEMORAL ARTERY. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE FIRST REVISION SURGERY WAS PERFORMED ARE NOT AVAILABLE. AS THE DATA COLLECTION HAS BEEN DONE RETROSPECTIVELY AND IS ANONYMIZED, FURTHER DETAILS ON HOW THIS ADVERSE EVENT WAS TREATED ARE UNKNOWN.

  Patient problems: Obstruction/Occlusion

  MAUDE report 12524167 ↗

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.