REDAPT 71354236Recalls & reported problems
Smith & Nephew, Inc. · REDAPT FULLY POROUS SHELL 62MM · Class 2 · Implant
Data updated Oct 13, 2026 from official FDA records · Editorial policy
- Adverse event reports
- 1
- Deaths reported
- 0
- Injuries reported
- 1
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556321546), received between Sep 16, 2024 and Sep 16, 2024 — classified as 1 injury.
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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem1
Patient problems
- Implant Pain1
Recent adverse event reports
The 1 most recent of 1 reports, in the reporter's own words as published by the FDA.
InjurySep 16, 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 RIGHT THA SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2020 DUE TO (1) ASEPTIC LOOSENING OF RIGHT TOTAL HIP ARTHROPLASTY, STATUS POST REVISION FOR ACETABULAR FRACTURE AND (2) DELAYED UNION OF ACETABULAR FRACTURE, COMPLICATED. DURING THE REVISION SURGERY, THE ACETABULAR SECTION OF THE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A REDAPT MODULAR ACETABULAR SYSTEM, ALONG WITH A SMITH AND NEPHEW ACETABULAR AUGMENT AND A COMPETITOR´S FEMORAL HEAD. AS REPORTED, THE PATIENT SUFFERED FROM PAIN DUE TO INTERNAL ORTHOPEDIC PROSTHETIC DEVICES, IMPLANTS AND GRAFTS. THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2023 TO ADDRESS THE ISSUES. DURING THIS SECOND REVISION SURGERY, THE ACETABULAR AUGMENT, SHELL, AND LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.
Patient problems: Implant Pain
MAUDE report 20233629 ↗
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Sources and updates
- Device record: FDA GUDID, file dated Oct 13, 2026 · View this device in AccessGUDID ↗
- Adverse event reports: FDA MAUDE, file dated Oct 13, 2026 · each report above links to its original FDA record
- Recalls: FDA Medical Device Recalls, file dated Oct 13, 2026
- Page last rebuilt: Oct 13, 2026. Data downloaded through openFDA, which notes it is not validated for clinical or regulatory use.
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