REDAPT 71354704Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556579299), received between Oct 27, 2021 and Oct 27, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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.

• InjuryOct 27, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2021, A PATIENT EXPERIENCED A FIRST REVISION SURGERY DUE TO FOR IMPINGEMENT, SUBSIDENCE OF POLARSTEM ON (B)(6) 2021 WHERE A REDAPT 240MM SLEEVELESS REVISION STEM SIZE 15 STANDARD OFFSET AND AN OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0 WERE IMPLANTED. THEN, ON (B)(6) 2021, THE PATIENT UNDERWENT A SECOND REVISION SURGERY DUE TO LOOSENING AND LEG LENGTH DISCREPANCY, SO THE REDAPT 240MM SLEEVELESS REVISION STEM SIZE 15 STANDARD OFFSET AND THE OXINIUM FEMORAL HEAD 12/14 TAPER 36 MM +0 WERE EXPLANTED AND REPLACED WITH A CPCS STEM. IN THE WORK UP, THE SURGEON COMMENTED THAT HE HAD UNDER REAMED/SIZED THE REDAPT STEM, HENCE IT SUBSIDING, SO THE IS NO FAULT PLACED ON THE DEVICE. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Unequal Limb Length

  MAUDE report 12707302 ↗

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.