REDAPT 71352356Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556657843), received between Feb 5, 2021 and Sep 17, 2024 — classified as 5 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K182109, 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 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

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

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY RIGHT HIP THA SURGERY ON (B)(6) 2022, DUE TO A TRAUMATIC CLOSED DISPLACED FRACTURE OF ACETABULUM. DURING THIS PROCEDURE, A COMPLETE REDAPT ACETABULAR SYSTEM WAS IMPLANTED WITH A CPCS FEMORAL SYSTEM. THE PATIENT SUFFERED FROM THE BREAKAGE OF THE INTERNAL RIGHT HIP PROSTHESIS AND SEPSIS. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2022. DURING THESE REVISION, THE ACETABULAR SHELL WAS EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Sepsis

  MAUDE report 20240739 ↗
• 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) 2021, DUE TO AN INFECTED TOTAL HIP ARTHROPLASTY. DURING THE REVISION SURGERY, THE PRIMARY THA ACETABULAR SYSTEM WAS EXPLANTED AND REPLACED WITH A THA ACETABULAR READAPT SYSTEM. THE IDENTITY OF THE HIP SYSTEM EXPLANTED DURING HTIS REVISION SURGERY IS UNKNOWN. AS REPORTED, THE PATIENT SUFFERED FROM AN INFECTED LEFT TOTAL HIP ARTHROPLASTY. THE ISSUE WAS RESOLVED BY PERFORMING A REVISION SURGERY ON (B)(6) 2021. IT IS UNKNOWN WHICH COMPONENTS WERE EXPLANTED DURING THIS REVISION SURGERY. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20238342 ↗
• 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 HER LEFT HIP ON NOV-2021 DUE TO A BROKEN FEMORAL STEM 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 FEMORAL REPADT SYSTEM. THE IDENTITY OF THE HIP SYSTEM EXPLANTED DURING THIS REVISION SURGERY IS UNKNOWN.AS REPORTED, THE PATIENT SUFFERED FROM A PERIPROSTHETIC JOINT INFECTION AND THE ISSUE WAS RESOLVED BY PERFORMING A 2 STAGE REVISION SURGERY ON AUG-2022 AND ON OCT-2022. DURING THIS REVISION SURGERY, ALL THE THA SYSTEM WAS EXPLANTED AND REPLACED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20238271 ↗
• InjuryJul 4, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A THR WAS PERFORMED ON (B)(6) 2021, PATIENT EXPERIENCED PERIPROSTHETIC INFECTION OF THE IMPLANT. THIS ADVERSE EVENT WAS ADDRESSED BY REVISION SURGERY ON (B)(6) 2024, IN WHICH THE WHOLE SYSTEM WAS EXCHANGE. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 19675008 ↗
• InjuryFeb 5, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A 2ND STAGE REVISION ON (B)(6) 2020 DUE TO A LEFT THR INFECTION, PATIENT HAD ANOTHER INFECTION IN THE SAME HIP THEREFORE HAD A FIRST STAGE REVISION LEFT THR ON (B)(6) 2021. IT WAS INDICATED BY A DISEASES SPECIALIST A REVISION SURGERY TO REMOVE ALL PROSTHESIS AS THE ORGANISM CAUSING THE INFECTION IS SUSCEPTIBLE TO ANTIBIOTIC THAT THE PATIENT IS ALLERGIC. ALL PROSTHESIS WERE REMOVED. PATIENT OUTCOME 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 11284765 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K182109, 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.