REDAPT 71354464Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556580585), 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. 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 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A PATIENT UNDERWENT A THR CONVERSION SURGERY ON THE RIGHT HIP ON (B)(6) 2018 TO TREAT A FEMORAL NONUNION DISTAL TO HEAD AND NECK. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 190MM SZ 15 SO WAS IMPLANTED. 4 MONTHS POSTOPERATIVELY, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO RECURRENT DISLOCATIONS, THE GREAT TROCHANTER HAVING PROXIMALLY MIGRATED, LEG EDEMA AND FRACTURE NON UNION. 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 THE PATIENT'S FINAL OUTCOME ARE UNKNOWN.

  Patient problems: Inadequate Osseointegration; Joint Dislocation; Nonunion/Delayed-union Bone Fracture; Swelling/ Edema

  MAUDE report 12524153 ↗

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.