REDAPT 71354234Recalls & reported problems

Summary

The FDA's MAUDE database contains 7 adverse event reports that list this exact device (DI 00885556321447), received between Nov 13, 2019 and Apr 28, 2026 — classified as 7 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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 7 most recent of 7 reports, in the reporter's own words as published by the FDA.

• InjuryApr 28, 2026Fracture

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON 2017, THE PATIENT EXPERIENCED THE BREAKAGE OF ONE (1) REDAPT FULLY POROUS SHELL 58MM. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2026, IN WHICH THE CUP WAS EXCHANGE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Insufficient Information; No Clinical Signs, Symptoms or Conditions

  MAUDE report 25024149 ↗
• InjuryJun 26, 2024Off-Label Use; Off-Label Use

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON (B)(6) 2024, IT WAS NOTICED THAT THE SURGEON IMPLANTED THE WRONG DEVICE: A REDAPT FULLY POROUS SHELL 58MM. EVEN THOUGH THE IMPLANT WAS LABELED CLEARLY, IT WAS OPENED AND IMPLANTED BY MISTAKE. DUE TO TWO INCOMPATIBLE IMPLANTS BEING PLACED IN THE PATIENT, A REVISION SURGERY WAS CONDUCTED THE NEXT DAY TO ADDRESS THIS EVENT. THE PATIENT HAS NOT PRESENTED FURTHER COMPLICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19614566 ↗
• InjuryOct 29, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  (B)(6). IT WAS REPORTED THAT AFTER A REVISION SURGERY TO A THA WAS PERFORMED ON (B)(6) 2018, THE PLAINTIFF EXPERIENCED LEFT HIP PAIN. A CT SCAN WAS PERFORMED ON (B)(6) 2018, AND 1-2 MM ACETABULAR PROTRUSION ON THE LEFT HIP, SUBTLE 1 MM FRACTURE ALONG THE INNER PELVIC BRIM ADJACENT TO THE ACETABULAR IMPLANT, AND SOME IRREGULARITY OF THE ACETABULAR RIM IMPLANT WERE FOUND. IT IS UNKNOWN IF OR HOW THESE FINDINGS WERE TREATED. ADDITIONAL INFORMATION IS UNKNOWN. PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Bone Fracture(s); Pain

  MAUDE report 12720602 ↗
• InjurySep 23, 2021Osseointegration Problem; Osseointegration Problem

  (B)(6) LEGAL. BILATERAL PATIENT. IT WAS REPORTED THAT, AFTER A PRIMARY REVISION SURGERY HAD BEEN PERFORMED ON THE PLAINTIFF¿S RIGHT HIP ON (B)(6) 2019, THE PLAINTIFF EXPERIENCED LOOSENING OF THE ACETABULAR SHELL IMPLANT DUE TO LOSS OF OSTEOINTEGRATION. A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO TREAT THIS ADVERSE EVENT; THE, REDAPT PT FULLY POROUS SHELL 58MM, 12/14 TAPER FEMORAL HEAD 36MM OXINIUM AND REDAPT CEMENTED LINER XLPE 36MMX58MM WERE EXPLANTED. THE PLAINTIFF WAS TAKEN TO RECOVERY ROOM IN GOOD CONDITION.

  Patient problems: Failure of Implant

  MAUDE report 12519828 ↗
• InjuryJan 16, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INFECTION. A NEW NON-READAPT POLAR CUP WAS IMPLANTED SO THE SUBJECT IS NO LONGER ENROLLED IN THE STUDY. THERE IS NO CONFIRMATION THAT THE OTHER DEVICES WERE FROM SMITH AND NEPHEW.

  Patient problems: Unspecified Infection

  MAUDE report 9598468 ↗
• InjuryJan 13, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  (B)(6). EVENT: IT WAS REPORTED THAT CLOSE REDUCTION WAS PERFORMED DUE TO A DISLOCATION OF LEFT HIP.

  Patient problems: Injury

  MAUDE report 9580025 ↗
• InjuryNov 13, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THIS WAS AN ONGOING ISSUE THE PATIENT ALREADY UNDERWENT A CLOSED REDUCTION DUE TO DISLOCATION ON 30 MAY 2017.

  Patient problems: Injury

  MAUDE report 9315159 ↗