REDAPT 71354723Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556579459), received between Sep 12, 2023 and Sep 12, 2023 — 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 12, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY WAS PERFORMED, THE PATIENT EXPERIENCED UNSPECIFIED SYMPTOM DUE TO FAILED GREATER TROCHANTER FIXATION IN PREVIOUS SURGERY AND SUBSEQUENT STEM SUBSIDENCE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2023, BUT IT WAS CANCELLED DUE TO THE SURGEON BEING UNWELL AND UNAVAILABLE TO PERFORM SURGERY ON THE DAY, SO IT WAS BOOKED TO (B)(6) 2023 IN WHICH THE STEM SUBSIDENCE RESULTED IN REDUCED LEG LENGTH AND AN INCISION WAS MADE. IN ADDITION, THE REDAPT SLVLS MONO STEM 240MM SZ 16 HO WAS EXCHANGED. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Insufficient Information

  MAUDE report 17730495 ↗

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.