REDAPT 71354722Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556579442), received between Sep 22, 2021 and Sep 18, 2024 — classified as 2 injuries.

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. 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjurySep 18, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT PATIENT UNDERWENT A RIGHT THA IN (B)(6) 2021 DUE TO RIGHT HIP OSTEOARTHRITIS. LATER, ON (B)(6) 2021 PATIENT SUFFERED FROM A RIGHT PERIPROSTHETIC FRACTURE. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY IN WHICH THE REDAPT 240MM SLEEVELESS REVISION STEM SIZE 15 HIGH OFFSET AND THE UNSPECIFIED SMITH & NEPHEW 32MM FEMORAL HEAD WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s)

  MAUDE report 20247176 ↗
• InjurySep 22, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AS PART OF AN UNSPECIFIED MEDICAL INDICATION, A PATIENT UNDERWENT A THR REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2016. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 240MM SZ 15 HO WAS IMPLANTED. AFTER THIS PROCEDURE, THE PATIENT FELT SOME DISCOMFORT WHILE WALKING. 6 MONTHS POSTOPERATIVELY, THE PATIENT EXPERIENCED PAIN, SWELLING AND A SPONTANEOUS PURULENT DISCHARGE FROM THE INCISION LINE IN THE BKA STUMP WHICH REQUIRED AN INCISION AND DRAINAGE OF THE STUMP. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE 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: Pain; Purulent Discharge; Swelling/ Edema; Unspecified Infection

  MAUDE report 12513775 ↗

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.