REDAPT 71354703Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556579282), received between Feb 17, 2018 and Mar 21, 2023 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (2 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMar 21, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  ON THE PMCF TITLED DCA-1000 ACCORD SS CLINICAL DATASET, IT WAS REPORTED THAT, AFTER UNDERGOING RIGHT THA, ONE (1) PATIENT EXPERIENCED A RIGHT PERIPROSTHETIC PROXIMAL FEMUR FRACTURE. THIS ADVERSE EVENT WAS TREATED BY PERFORMING REVISION SURGERY COMBINED WITH INTERNAL FIXATION ON (B)(6) 2022, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP DETERMINED THAT THE PATIENT PRESENTS CONSOLIDATION OF PERIPROSTHETIC FRACTURE WITH NO MIGRATION OF TROCHANTER.

  Patient problems: Hip Fracture

  MAUDE report 16583772 ↗
• InjuryNov 6, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO INFECTION. HIP PREPPED AND DRAPED JOINT OPENED. SPECIMENS TAKEN JOINT LAVAGED AND DEBRIDED INTENSELY W HYDROGENS PEROXIDE. ACETABULUM EXPOSED AND REAMED. CUP TRIALED. CEMENTED CUP APPLIED. THE FEMORAL CANAL REAMED. REDAPT STEM TRIALED W REDUCTION. THE STABLE JOINT CAPSULE AND LEG LENGTH ACHIEVED DEFINITIVE IMPLANTS INSERTED. HIP REDUCED. HIP CLOSED

  Patient problems: Unspecified Infection

  MAUDE report 9284152 ↗
• InjuryFeb 17, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A SURGICAL INTERVENTION WAS PERFORMED DUE TO A SUBSIDED STEM. THE STEM WAS REMOVED AND REPLACED.

  Patient problems: Limited Mobility Of The Implanted Joint

  MAUDE report 7279365 ↗

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.