REDAPT 71354632Recalls & reported problems

Summary

The FDA's MAUDE database contains 14 adverse event reports that list this exact device (DI 00885556578612), received between Feb 27, 2020 and Sep 19, 2024 — classified as 1 injury, 13 malfunctions.

The most frequently reported specific device problem is “Break” (8 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 14 most recent of 14 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 19, 2024Positioning Failure; Detachment of Device or Device Component; Positioning Failure; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THR SURGERY, WHEN PLACING ONE (1) REDAPT TRIAL BODY SZ 16 + ON TOP OF THE DISTAL REAMER AND LIGHTLY PRESSING IT DOWN TO SEAT, IT WOULD NOT CONNECT. WHEN ATTEMPTING TO PULL IT OUT, THE DEVICE CAME APART, INCLUDING A SPRING. THE PIECES THAT DETACHED WERE RETRIEVED FROM THE PATIENT USING TWEEZERS. THE PROCEDURE RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITHOUT TRIALING THE STEM AND ONLY TRIALING THE HEAD. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20262679 ↗
• MalfunctionDec 5, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT DURING A THR, THE 2 GEARS OF A REDAPT TRIAL BODY SZ 16 + SEPARATED. THERE WAS A NON-SIGNIFICANT DELAY AND THE PROCEDURE WAS FINISHED USING THE SAME DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18267470 ↗
• MalfunctionOct 2, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR SURGERY, ONE (1) REDAPT TRIAL BODY SZ 16 + FRACTURED INTO 2 PIECES IN THE MIDDLE PART. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17851802 ↗
• MalfunctionMay 12, 2023Fracture; Detachment of Device or Device Component; Fracture; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THA, A REDAPT TRIAL BODY SZ 16 + BROKE. ADDITIONALLY, PIECES FELL INTO THE PATIENT'S ANATOMY. IT IS UNKNOWN HOW THE PIECE WAS RETRIEVED. SURGERY WAS RESUMED, WITH A NON-SIGNIFICANT DELAY, WITHOUT TRIALING. NO PATIENT HARM HAS BEEN REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16924858 ↗
• MalfunctionApr 13, 2023Fracture; Fracture

  IT WAS REPORTED THAT DURING A THR, ONE (1) REDAPT TRIAL BODY SZ 16 + DISASSEMBLED IN THE MIDDLE PART, AFTER REMOVING. IT WAS NOTICED TO BE FRACTURED IN HALF. NO PIECES FELL INTO PATIENT. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16735725 ↗
• MalfunctionJun 11, 2022Break; Break

  IT WAS REPORTED THAT THE REDAPT TRIAL BODY SZ 16 + WAS DAMAGED. NO CASE INVOLVED; THEREFORE, THERE WAS NO PATIENT INVOLVEMENT. UPON INVESTIGATION IT WAS FOUND THAT THE METAL ON THE DEVICE IS CHIPPED OFF.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671112 ↗
• InjuryMay 18, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE REDAPT TRIAL BODY SZ 16 + WAS BROKEN. SURGERY WAS RESUMED, WITHOUT ANY DELAY, WITH A SMITH AND NEPHEW BACK-UP DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14431784 ↗
• MalfunctionMay 4, 2022Break; Break

  IT WAS REPORTED THAT, AFTER A THR SURGERY, WHILE CLEANING THE INSTRUMENTS, IT WAS NOTICED THAT A REDAPT TRIAL BODY SIZE 16 + BROKE. SURGERY WAS PERFORMED, WITHOUT ANY DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14283765 ↗
• MalfunctionMar 29, 2022Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REDAPT TRIAL BODY SZ 16 BROKE. NO PIECE FELL INTO THE PATIENT. SURGERY WAS FINISHED WITH THE SAME DEVICE, WITHOUT ANY DELAY. NO HARM TO THE PATIENT OR FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13935622 ↗
• MalfunctionNov 25, 2021Break; Break

  IT WAS REPORTED THAT, A REDAPT TRIAL BODY SZ 16 + WAS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12874483 ↗
• MalfunctionJul 15, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR SURGERY, SURGEON WAS ATTEMPTING TO REMOVE THE SIZE 22 REDAPT DISTAL REAMER BUT IT BECAME STUCK IN THE PATIENT'S CANAL. IN AN ATTEMPT TO EXTRACT THE DISTAL REAMER, THE SURGEON ATTACHED THE REDAPT TRIAL BODY SIZE 16 + TO THE DISTAL REAMER AND BEGAN THE EXTRACTION ATTEMPT. DURING THE PROCESS, REDAPT TRIAL BODY SIZE 16 + BROKE OFF OF THE DISTAL REAMER AND WAS NO LONGER USABLE. AS THE TRIAL BROKE OUT OF THE PATIENT, NO BROKEN PIECES FROM THE INSTRUMENT FELL IN TO THE PATIENT'S WOUND. SURGERY WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12171146 ↗
• MalfunctionApr 18, 2021Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE 16+ TRIAL ASSEMBLY COMES APART. IT IS UNSURE IF THE DAMAGE TOOK PLACE IN THE CASE OR IF IT WAS AN EXISTING PROBLEM UPON RECEIPT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11683581 ↗
• MalfunctionJun 25, 2020Break; Break

  IT WAS REPORTED THAT DURING AN UNKNOWN PROCEDURE, THE ITEM WAS FOUND BROKEN. NO INJURIES OR SURGICAL DELAYS WERE REPORTED. NO INFORMATION ABOUT BACKUP DEVICES WAS PROVIDED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10193952 ↗
• MalfunctionFeb 27, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE INSTRUMENT BROKE. FRACTURED AT THE POKER CHIP JUNCTION IT WAS INSIDE THE PATIENT AND ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED USING AN S AND N BACKUP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9762536 ↗