REDAPT 71354739Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556579602), received between Nov 27, 2017 and Sep 30, 2019 — classified as 2 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 30, 2019Material Separation; Material Separation

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO A DISASSOCIATION OF THE HEAD AND THE STEM. THE REDAPT STEM WAS REPLACED.

  Patient problems: Injury

  MAUDE report 9137586 ↗
• InjuryNov 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THE PATIENT UNDERWENT AN ELECTIVE RTHA REVISION. THE PATIENT SUFFERED A DISTAL FRACTURE ((B)(6)), TROCHANTER FRACTURE FRAGMENTS ((B)(6) 2017), AND FRACTURE OF THE MIDDIAPHYSIS OF RIGHT FEMUR ((B)(6) 2017). THE HIP HAS DISLOCATED TWICE (B)(6). THE STEM CONTINUES TO SUBSIDE. THE PATIENT ALSO DEVELOPED AN INFECTION.

  Patient problems: Bone Fracture(s); Unspecified Infection

  MAUDE report 7059795 ↗

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.