REDAPT 71354708Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556579336), received between Sep 23, 2021 and Sep 16, 2024 — classified as 2 injuries, 1 malfunction.

The most frequently reported specific device problem is “Fracture” (1 report).

1 other recall cover devices cleared under the same FDA submission (K151902, K211176); 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 3 most recent of 3 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 LEFT THA SYSTEM (UNKNOWN PRODUCT) ON (B)(6) 2020 DUE TO (1) LEFT PERIPROSTHETIC DISTAL FEMUR FRACTURE AND (2) PERIPROSTHETIC JOINT INFECTION. DURING THE REVISION SURGERY, THE WHOLE PRIMARY THA SYSTEM WAS EXPLANTED AND REPLACED WITH A REDAPT MODULAR SHELL AND A REDAPT FEMORAL SYSTEM. AS REPORTED, THE PATIENT SUFFERED FROM A LEFT PERIPROSTHETIC DISTAL FEMUR FRACTURE. THE PATIENT UNDERWENT A REVISION SURGERY WITHIN THE SAME MONTH TO ADDRESS THE ISSUES. DURING THIS SECOND REVISION SURGERY, IT IS UNKNOWN WHICH SPECIFIC PRODUCTS WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Hip Fracture

  MAUDE report 20233249 ↗
• MalfunctionOct 23, 2023Fracture; Fracture

  IT WAS REPORTED THAT, IN A THR SURGERY, UPON INSERTION OF ONE (1) REDAPT SLVLS MONO STEM 240MM SZ 19 SO, THE THREADED PORTION SHEARED OFF IN THE LATERAL INSERTION HOLE ON THE STEM. THE STEM WAS EXPLANTED TO LEAVE A FOREIGN BODY IN THE PATIENT. THE PROCEDURE WAS RESUMED, AFTER A NON-SIGNIFICANT DELAY, WITH 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 17986257 ↗
• InjurySep 23, 2021Osseointegration Problem; Osseointegration Problem

  IT WAS REPORTED THAT, AS PART OF AN UNSPECIFIED FEMORAL SHAFT FIXATION, A PATIENT UNDERWENT A THR REVISION SURGERY ON (B)(6) 2016 ON THE LEFT HIP. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 240MM SZ 19 SO WAS IMPLANTED. THREE MONTHS LATER, A SUBSIDENCE AND ASEPTIC LOOSENING OF THE FEMORAL STEM, IN ADDITION TO A LIMB LENGTH DISCREPANCY AND A PERIPROSTHETIC FRACTURE WERE NOTICED, WHICH LED TO A SECOND REVISION SURGERY BEEN PERFORMED ON (B)(6) 2017 TO TREAT THIS ADVERSE EVENT. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE FIRST REVISION SURGERY WAS PERFORMED ARE NOT AVAILABLE. AS THE DATA COLLECTION HAS BEEN DONE RETROSPECTIVELY AND IS ANONYMIZED, FURTHER DETAILS ON THE PATIENT'S FINAL OUTCOME ARE UNKNOWN.

  Patient problems: Bone Fracture(s); Inadequate Osseointegration; Unequal Limb Length

  MAUDE report 12523852 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K151902, K211176. One submission often covers many models, so check the product and lot details in each record.

• Z-0326-2025 · Oct 15, 2024 · Open, Classified
  Tandem Intl Bipolar Cocr Shell/UHMWPE Liner, TI-6AL-4V Retaining Ring, 28MM I.D. 46 MM O.D., REF 71324046, sterile, femoral head bipolar component of the Tandem Bipolar Hip System.