REDAPT 71352358Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556657850), received between Mar 21, 2023 and Jun 17, 2024 — classified as 2 injuries.

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.

• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A LEFT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED; PATIENT SUSTAINED A SEPSIS THAT REQUIRED READMISSION ON (B)(6) 2020. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Sepsis

  MAUDE report 19553149 ↗
• 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 LEFT THA, ONE (1) PATIENT EXPERIENCED FAILURE OF THE THA SYSTEM. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY COMBINED WITH INTERNAL FIXATION ON (B)(6) 2021, IN WHICH AN ACCORD CABLE SYSTEM WAS IMPLANTED. A POST-OPERATIVE FOLLOW-UP DETERMINED A GOOD POSITION WITHOUT COMPLICATING FEATURES.

  Patient problems: Failure of Implant

  MAUDE report 16583186 ↗