REDAPT 71354706Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556579312), received between Dec 27, 2021 and Dec 27, 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.

• InjuryDec 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A PARTIAL ARTHROPLASTY HAD BEEN PERFORMED ON (B)(6) 2021 TO REPAIR A FEMUR FRACTURE, THE PATIENT HAD TWO CONSECUTIVE FALLS AFTERWARDS, WHICH CAUSED TEARS IN ALL SOFT TISSUE SUPPORT STRUCTURES AROUND THE HIP JOINT. REDAPT SLVLS MONO STEM 240MM SZ 17 SO, COCR 12/14 FEM HEAD 28 +0 AND TANDEM INTL BIPOLAR 46OD 28ID WERE EXPLANTED. THE PATIENT WAS LEFT WITH A GURDLE STONE HIP. THE PATIENT CURRENT HEALTH STATUS IS GOOD.

  Patient problems: Rupture

  MAUDE report 13089662 ↗

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.