REDAPT 71354468Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556580622), received between Feb 1, 2021 and Feb 1, 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.

• InjuryFeb 1, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THE SECOND SURGERY DUE TO THE FRACTURE ON AUGUST 2020 THE PATIENT GOT INFECTED THEREFORE IT WAS DONE A REVISION SURGERY ON 01/07/2021. ALL IMPLANTS WERE REMOVED. ( OXINIUM FEM HD 12/14 36 MM -3, REDAPT SLVLS MONO STEM 190MM SZ 19 SO, R3 3 HOLE ACET SHELL 58MM, R3 20 DEG XLPE ACET LNR 36MM X 58MM, TWO REF SPHER HEAD SCREW 20MM, THREE ACC 2.0MM COCR CABLE W/CLAMP.) THOSE IMPLANTS WERE REPLACED, EXCEPTED FOR THE FLEXIBLE OSTEOTOMES USED TO REMOVE THE REDAPT SLVLS MONO STEM 190MM SZ 19 SO AND ALSO WAS IMPLANTED FOUR CC 2.0MM COCR CABLE W/CLAMP. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Post Operative Wound Infection

  MAUDE report 11263409 ↗

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.