REDAPT 71354631Recalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00885556578605), received between Dec 10, 2019 and May 1, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (3 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 1, 2026Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REDAPT TRIAL BODY SZ 12-15 OUTER SLEEVE CAME OFF DURING STANDARD USAGE. NO FRAGMENTS FELL INTO THE PATIENT. THE PROCEDURE WAS PERFORMED, WITHOUT ANY DELAY, USING AN EQUIVALENT S+N BACK- UP. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25062113 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, ONE (1) REDAPT TRIAL BODY SZ 12-15 BROKE INTO TWO PIECES WHILE SURGEON WAS EXPLAINING THE DEVICE FROM THE STEM. IT IS UNKNOWN IF ANY PIECE FELL INSIDE THE INCISION. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING THE SAME DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21873735 ↗
• MalfunctionNov 12, 2024Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, WHEN REMOVING THE TRIAL COMPONENTS WITH THE HOOK AFTER IMPACTION, THE BODY OF ONE (1) REDAPT TRIAL BODY SZ 12-15 DISCONNECTED, AND THE WAVE SPRING POPPED OUT FALLING INTO THE SURGICAL TABLE. THE PROCEDURE WAS RESUMED WITHOUT DELAY USING A SMITH AND NEPHEW BACKUP DEVICE, AND NO INJURIES WERE REPORTED AS A RESULT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20662432 ↗
• MalfunctionJul 6, 2023Detachment of Device or Device Component; Detachment of Device or Device Component

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE SPRING OF A REDAPT TRIAL BODY SZ 12-15 WAS FOUND TO BE MISSING AND THE DEVICE DISASSOCIATED WHEN ATTEMPTING TO TRIAL. THERE WAS NO SURGICAL DELAY; HOWEVER, IT IS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17273886 ↗
• MalfunctionNov 25, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING TOTAL HIP REPLACEMENT, A REDAPT TRIAL BODY SIZE 12-15 BROKE IN PIECES WHILE TRIALING. IT IS UNKNOWN IF PIECES FELL INSIDE THE PATIENT AND HOW SURGERY WAS COMPLETED OR IF THERE WAS A DELAY. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15864608 ↗
• InjuryJun 12, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR PROCEDURE, WHILE TRYING TO EXTRACT FROM THE PATIENT THE PROXIMAL REDAPT TRIAL BODY SZ 12-15 BROKE. ALL PIECES OF THE MECHANISM WERE FOUND AND EXTRACTED VIA C-ARM. SURGERY WAS RESUMED, WITH A LESS THAN OR EQUAL TO 30 MINUTES DELAY, WITH THE SAME DEVICE. PATIENT WAS NOT HARMED. NO FURTHER COMPLICATIONS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14671974 ↗
• InjuryJun 10, 2021Break; Fitting Problem; Break; Fitting Problem

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE PROXIMAL REDAPT TRIAL BODY SZ 12-15 (B)(4) COULD NOT BE FULLY SEATED. IT WAS TAPPED DOWN, AND UPON ATTEMPT TO EXTRACT WITH THE HOOK EXTRACTOR IT CAME APART AT THE PIVOTING JUNCTION LEAVING THE DISTAL PART BEHIND AND THE PIECE WAS REMOVED. ALSO, THE FEMORAL HEAD/NECK IMPACTOR (B)(4) CORNER BROKE OFF WHEN REMOVING FEMORAL HEAD; THE PIECE WAS RETRIEVE. INSTRUMENTS INTERNAL TO PATIENT. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY AND IT WAS UNKNOWN HOW THE PROCEDURE WAS FINISHED. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11977183 ↗
• MalfunctionMay 13, 2021Incomplete or Inadequate Connection; Incomplete or Inadequate Connection

  IT WAS REPORTED THAT, DURING A THR, A REDAPT TRIAL BODY SZ 12-15 WAS NOT WORKING PROPERLY. INSTRUMENT OUTSIDE THE PATIENT. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A S+N BACK-UP DEVICE. PATIENT WAS NOT HARMED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11820581 ↗
• MalfunctionDec 10, 2019Break; Break

  IT WAS REPORTED THAT DURING SURGERY DEVICE BROKE INSIDE THE PATIENT, ALL PIECES WERE RECOVERED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING AN S&N BACK-UP DEVICE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9446625 ↗