REDAPT 71354758Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556579770), received between Jul 30, 2022 and Jul 30, 2022 — 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.

• InjuryJul 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT TKA INITIAL SURGERY PERFORMED ABOUT TWO YEARS AGO, THE PATIENT FALL RESULTING IN A FRACTURED FEMUR WHICH LEAD TO REDAPT SLVLS MONO STEM 300MM SZ 16 {} HO SUBSIDENCE OF THE REDAPT STEM THAT WAS ALREADY IN-SITU. BOTH THE REDAPT SLVLS MONO STEM 300MM SZ 16 {} HO AND THE BIOLOX OPTION CE BALL HEAD 12/14 36S WERE EXPLANTED. NEW REDAPT STEM AND HEAD PLACED WITHOUT ISSUE. FURTHER INFORMATION IS UNKNOWN AND UNAVAILABLE.

  Patient problems: Deformity/ Disfigurement; Fall; Hip Fracture; Limb Fracture

  MAUDE report 15136793 ↗

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.