REDAPT 71354757Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556579763), 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 FEMORAL SHAFT FIXATION, A PATIENT UNDERWENT A THR REVISION SURGERY ON (B)(6) 2017 ON THE RIGHT HIP. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 300MM SZ 15 HO WAS IMPLANTED. AFTER THIS PROCEDURE, THAT PATIENT EXPERIENCED INSTABILITY EPISODES, DISCOMFORT, HETEROTROPHIC OSSIFICATION AND LOSS OF FIXATION OF PERIPROSTHETIC FRACTURE, WHICH LED TO MULTIPLE CLOSED REDUCTIONS TO TREAT THIS ADVERSE EVENT. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE REVISION SURGERY WAS PERFORMED ARE NOT AVAILABLE. AS THE DATA COLLECTION HAS BEEN DONE RETROSPECTIVELY AND IS ANONYMIZED, FURTHER DETAILS ON THE PATIENT'S FINAL OUTCOME ARE UNKNOWN.

  Patient problems: Discomfort; Extraskeletal ossification; Joint Laxity; Nonunion/Delayed-union Bone Fracture

  MAUDE report 12524122 ↗

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.