REDAPT 71352354Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 00885556657836), received between Nov 12, 2022 and Sep 10, 2025 — classified as 4 injuries.

The most frequently reported specific device problem is “Biocompatibility” (1 report).

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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjurySep 10, 2025Biocompatibility; Biocompatibility

  IT WAS REPORTED THAT, AFTER A THR FIRST REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 DUE TO DISLOCATION AND S+N DEVICES WERE IMPLANTED, AN ADDITIONAL REVISION SURGERY IS REQUIRED IN THE NEAR FUTURE, AS THE PATIENT IS EXPERIENCING ELEVATED METAL ION LEVELS.

  Patient problems: High metal ion levels

  MAUDE report 23017713 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A LEFT HIP THA CONVERSION SURGERY ON (B)(6) 2022, DUE TO A NONUNION OF INTERTROCHANTERIC FEMUR FRACTURE WITH SCREW CUT-OUT. DURING THIS PROCEDURE, A REDAPT ACETABULAR AND FEMORAL SYSTEM WERE IMPLANTED. THE IDENTITY OF THE PRIMARY FIXATION SYSTEM IS UNKNOWN. THE PATIENT SUFFERED FROM CELLULITIS ON (B)(6) 2022 AND REQUIRED READMISSION TO THE HOSPITAL. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Cellulitis

  MAUDE report 20241331 ↗
• InjurySep 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY OF THE LEFT HIP ON (B)(6) 2022, DUE TO SUBSIDENCE AND LOOSENING FOLLOWING LEFT TOTAL HIP ARTHROPLASTY. DURING THE REVISION SURGERY, THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR REDAPT SYSTEM AND A REDAPT FEMORAL SYSTEM. THE IDENTITY OF THE HIP SYSTEM IMPLANTED BEFORE THIS REVISION SURGERY IS UNKNOWN. AS REPORTED, THE PATIENT SUFFERED FROM ACCUTE POST OP HEMORRHAGE ANEMIA DURING HER STAY IN THE HOSPITAL. ALSO, ON (B)(6) 2022 THE PATIENT KEPT EXPERIENCING ANEMIA AND SUFFERED FROM DVT. THE ISSUE RESULTED IN THE READMISSION OF THE PATIENT INTO THE HOSPITAL. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Anemia; Thrombosis/Thrombus

  MAUDE report 20238984 ↗
• InjuryNov 12, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A REDAPT THR SURGERY PERFORMED ON (B)(6) 2021, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022, DUE TO INFECTION. ALL COMPONENTS WERE EXTRACTED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Unspecified Infection

  MAUDE report 15785906 ↗