REDAPT 71355107Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00885556223697), received between Jun 12, 2018 and Dec 11, 2025 — classified as 4 injuries, 22 malfunctions.

The most frequently reported specific device problem is “Break” (15 reports).

1 other recall cover devices cleared under the same FDA submission (K121627); 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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionDec 11, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR REVISION SURGERY, WHEN REMOVING THE REDAPT STEM USING THE REDAPT STEM EXTRACTOR UNIV JOINT, THE THREADED PIECE BROKE AND WAS LEFT IN THE STEM. NO PIECES FELL INSIDE THE SURGICAL SITE. SURGERY WAS COMPLETED, WITHOUT ANY DELAY, BY REMOVING THE STEM USING A VICE GRIP AND SLAP HAMMER FROM INNOMED. NO FURTHER COMPLICATIONS WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23782552 ↗
• MalfunctionJul 23, 2025Break; Break

  IT WAS REPORTED THAT, DURING THR SURGERY, ONE (1) REDAPT STEM EXTRACTOR UNIV JOINT WAS BROKEN. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22576015 ↗
• MalfunctionApr 21, 2025Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, A REDPAPT STEM WAS PLACED. THE STEM WAS ABOUT 2CM PROUD. THE REDAPT STEM EXTRACTOR UNIV JOINT WAS SCREWED IN AND WHILE SLAPPING IT OUT THE TIP BROKE OFF IN THE STEM. THE PROCEDURE WAS RESUMED, AFTER A SIGNIFICANT DELAY, WITH A COMPETITOR'S DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21875772 ↗
• MalfunctionSep 30, 2024Fracture; Fracture

  IT WAS REPORTED THAT DURING THR SURGERY, THREADED PORTION OF THE REDAPT STEM EXTRACTOR UNIV JOINT BROKE OFF IN THE REDAPT STEM WHILE TRYING TO EXTRACT IT. THE PROCEDURE WAS ABLE TO BE COMPLETED WITH THE SAME DEVICE. SURGERY WAS NOT DELAYED. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20333708 ↗
• MalfunctionSep 5, 2024Fracture; Fracture

  IT WAS REPORTED THAT, DURING IMPLANT EXTRACTION IN A THR SURGERY, ONE (1) REDAPT STEM EXTRACTOR UNIV JOINT GOT BROKEN OFF UPON BEING ATTACHED INSIDE ONE (1) UNKNOWN 19X240 HO REDAPT STEM. THE IMPLANT SAT HIGHER THAN ANTICIPATED, DUE TO BONE STRENGTH. THE PRIMARY IMPLANT EXTRACTION WAS REQUIRED FOR MORE BONE REAMING AS THE HIP COULD NOT BE REDUCED WITH THE 3 FEMORAL HEAD. THIS WAS A PRIMARY SURGERY BUT DUE TO THE PATIENT´S ANATOMY, IT REQUIRED A REVISION STEM. NO PIECE FELL INSIDE THE PATIENT, AS THE BROKEN PIECE STAYED INSIDE THE STEM WHICH WAS REMOVED. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, USING A COMPETITOR¿S DEVICE. NO INJURY WAS REPORTED AS A RESULT OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20146676 ↗
• MalfunctionJul 17, 2024Fracture; Deformation Due to Compressive Stress; Damaged Thread; Fracture; Deformation Due to Compressive Stress; Damaged Thread

  IT WAS REPORTED THAT, DURING STEM EXTRACTION IN A THA SURGERY, ONE (1) REDAPT STEM EXTRACTOR UNIV JOINT BECAME STRIPPED. THE ATTACHED PHOTOGRAPHS SHOW A FRACTURE IN THE DEVICE´S THREADING. THE PROCEDURE WAS RESUMED, WITHOUT ANY DELAY, USING A S+N BACK-UP DEVICE. NO INJURY WAS REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19759281 ↗
• MalfunctionOct 22, 2022Fracture; Fracture

  IT WAS REPORTED THAT, DURING A THR SURGERY, THE THREADS OF A REDAPT STEM EXTRACTOR UNIV JOINT BROKE DURING STEM EXTRACTION. IT IS NOT KNOWN IF THERE WAS A DELAY IN THE SURGERY AND HOW IT WAS COMPLETED. HOWEVER, NO HARM TO THE PATIENT WAS REPORTED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15656080 ↗
• MalfunctionSep 9, 2022Fracture; Fracture

  IT WAS REPORTED THAT THE THREADS OF A REDAPT STEM EXTRACTOR UNIVERSAL JOINT ARE BROKEN OFF. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15395987 ↗
• MalfunctionFeb 16, 2022Break; Material Twisted/Bent; Break; Material Twisted/Bent

  IT WAS REPORTED THAT THE REDAPT STEM EXTRACTOR BROKE. IT IS UNKNOWN WHETHER THIS PROBLEM WAS NOTICED IN A SURGICAL ENVIRONMENT OR NOT; THEREFORE, PATIENT INVOLVEMENT HAS NOT BEEN CONFIRMED.

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

  MAUDE report 13545161 ↗
• MalfunctionJan 6, 2022Crack; Crack

  IT WAS REPORTED THAT WHEN EXTRACTING THE STEM DURING THR SURGERY, THE GREEN PLASTIC PIECE OF A REDAPT STEM EXTRACTOR UNIV JOINT CRACKED OUTSIDE THE PATIENT. SURGERY WAS RESUMED, 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 13177011 ↗
• MalfunctionJan 4, 2022Break; Break

  IT WAS REPORTED THAT A REDAPT STEM EXTRACTOR UNIVERSAL JOINT WAS FOUND WITH A BROKEN PIECE. AS THIS WAS NOTICED IN A NON-SURGICAL ENVIRONMENT, THERE WAS NOT ANY PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13158900 ↗
• MalfunctionNov 7, 2021Break; Break

  IT WAS REPORTED THAT THE THREADED SHAFT OF THE REDAPT STEM EXTRACTOR UNIV JOINT IS BROKEN. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NO PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12760157 ↗
• MalfunctionSep 28, 2021Crack; Crack

  IT WAS REPORTED THAT A REDAPT STEM EXTRACTOR UNIV JOINT IS CRACKED ON THE GREEN MATERIAL. NO PATIENT INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12538477 ↗
• MalfunctionSep 27, 2021Crack; Material Deformation; Crack; Material Deformation

  IT WAS REPORTED THAT, A REDAPT STEM EXTRACTOR UNIV JOINT WAS CRACKED AND THREADS WERE STRIPPED. AS THIS WAS NOTICED UPON FIELD INSPECTION, THERE WAS NOT PATIENT INVOLVEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12532352 ↗
• InjuryApr 19, 2021Break; Break

  IT WAS REPORTED THAT, DURING REVISION SURGERY, WHILE TRYING TO EXPLANT THE STEM, THE THREADS OF THE UNIVERSAL JOINT STEM EXTRACTOR BROKE OFF INSIDE THE PATIENT IN THE THREADED PROXIMAL PORTION OF THE STEM. ALL PIECES WERE RETRIEVED. THE PROCEDURE WAS COMPLETED WITHOUT DELAY USING A SMITH AND NEPHEW BACK-UP DEVICE. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Foreign Body In Patient

  MAUDE report 11689758 ↗
• InjuryJan 11, 2021Break; Break

  IT WAS REPORTED THAT, DURING A THR THE THREADED TIP OF THE REDAPT STEM EXTRACTOR UNIV JOINT BROKE. INSTRUMENTS INSIDE THE PATIENT. THE THREADS BROKE OFF INSIDE THE ANTHOLOGY STEM SO NOTHING WAS LEFT INSIDE PATIENT. IT WAS REMOVED WHEN THE STEM WAS REMOVED. THE PROCEDURE WAS COMPLETED WITH A DELAY LESS THAN OR EQUAL TO 30MIN, USING A SMITH-NEPHEW BACK-UP DEVICE. NO PATIENT INJURY OR OTHER COMPLICATIONS WERE REPORTED. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11150946 ↗
• MalfunctionNov 27, 2020Break; Break

  IT WAS REPORTED THAT DURING EFIP INSPECTION IT WAS NOTICED A FAILURE BROKEN TIP. NO CASE INVOLVED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 10912981 ↗
• InjuryOct 27, 2020Break; Break

  IT WAS REPORTED THAT DURING TOTAL HIP REPLACEMENT THE REDAPT STEM EXTRACTOR UNIV JOINT TIP BROKE IN THE IMPLANTED STEM. THE DOCTOR ENDED UP LEAVING THE STEM IN. IT IS UNKNOWN IF THERE WAS A DELAY IN THE CASE. THE PROCEDURE WAS COMPLETED WITH THE SAME DEVICE.

  Patient problems: Foreign Body In Patient; No Known Impact Or Consequence To Patient

  MAUDE report 10743758 ↗
• MalfunctionSep 8, 2020Break; Break

  IT WAS REPORTED THAT AFTER CASE IT WAS FOUND THAT THE THREAD ON TIP OF THE REDAPT STEM EXTRACTOR UNIV JOINT BROKE OFF. NO INJURIES OR SURGICAL DELAYS REPORTED.

  Patient problems: No Patient Involvement

  MAUDE report 10505777 ↗
• MalfunctionAug 19, 2020Break; Break

  IT WAS REPORTED THAT DURING INSPECTION WAS NOTICED THAT THE REDAPT STEM EXTRACTOR UNIV JOINT IS BROKEN. THERE WAS NO PATIENT INVOLVED.

  Patient problems: No Patient Involvement

  MAUDE report 10427024 ↗
• MalfunctionJul 12, 2020Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE DEVICE JOINT GOT BROKEN. THERE WAS NO DELAY NOR INJURY REPORTED. THE PROCEDURE WAS FINISHED WITH THE SAME DEVICE. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10262239 ↗
• MalfunctionSep 16, 2019Fracture; Fracture

  IT WAS REPORTED THAT DURING SURGERY, THE GREEN PLASTIC SPACER ON THE STEM EXTRACTOR TIP BROKE OFF. THE BROKEN PIECE WAS RETRIEVED AND NO BROKEN PIECES WERE LEFT INSIDE THE PATIENT. NO INJURY. NO DELAY AND A BACKUP DEVICE WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9070290 ↗
• MalfunctionJun 24, 2019Break; Break

  IT WAS REPORTED THAT THE THREADS BROKE OFF WHILE BACK SLAPPING THE EXTRACTION HANDLE WHEN TRYING TO REMOVE A REDAPT STEM. NO DELAY AND BACK-UP DEVICE WAS AVAILABLE.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8727950 ↗
• MalfunctionApr 2, 2019Break; Break

  IT WAS REPORTED THAT DURING REVISION SURGERY AFTER REMOVING THE REDAPT STEM EXTRACTOR, THE SURGEON NOTICED THAT THIS PART HAD CRACKED FROM THE EXTRACTION PROCESS. NO DELAY OR PATIENT INJURY REPORTED. THE REP STATED THAT ALL PIECES WERE RECOVERED.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 8475264 ↗
• MalfunctionAug 22, 2018Break; Break

  IT WAS REPORTED THAT DURING SURGERY THE EXTRACTOR BROKE AT THE THREADS.

  Patient problems: No Information

  MAUDE report 7806950 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K121627. One submission often covers many models, so check the product and lot details in each record.

• Z-0944-2017 · Nov 15, 2016 · Terminated
  Modular REDAPT(TM) Hip Systems The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments