REDAPT 71354807Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556579961), received between Sep 24, 2021 and Apr 19, 2024 — classified as 2 injuries.

1 other recall cover devices cleared under the same FDA submission (K162303, 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.

• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, DURING A LEFT THA CONVERSION PERFORMED ON AN UNKNOWN DATE DUE TO LEFT HIP OSTEOARTHRITIS WITH A PRIOR NAIL STABILIZATION OF A FEMORAL FRACTURE, THE PATIENT SUSTAINED AN INTRAOPERATIVE GREATER TROCHANTERIC FRACTURE. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Bone Fracture(s)

  MAUDE report 19149448 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 9 WEEKS AFTER A MEDICALLY INDICATED CONVERSION OF PREVIOUS RIGHT HIP SURGERY TO TOTAL HIP ARTHROPLASTY PERFORMED ON (B)(6) 2018, WHERE REDAPT SLVD MONO STEM 240MM SZ 18 SO WAS IMPLANTED, THE PATIENT REPORTED POSTOPERATIVE BACTEREMIA. IT WAS NOT REPORTED HOW THE BACTEREMIA WAS TREATED. THE PATIENT ALSO REPORTED INCREASING PAIN IN GROIN AREA 3 YEARS AFTER SURGERY. IT IS UNKNOWN IF OR HOW THE ADVERSE EVENT WAS TREATED. ADDITIONAL DETAILS ABOUT PRIMARY SURGERY ARE UNKNOWN. THIS DE-IDENTIFIED CLINICAL DATA IS RELATED TO A POST MARKET CLINICAL FOLLOW-UP ACTIVITY FOR REDAPT SLEEVED MONO STEMS. AS THE DATA COLLECTION ACTIVITY HAS BEEN DONE RETROSPECTIVELY AND DATA IS PROVIDED ANONYMIZED, THE INFORMATION PROVIDED IS LIMITED AND FURTHER INFORMATION CANNOT BE OBTAINED.

  Patient problems: Bacterial Infection; Pain

  MAUDE report 12524203 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K162303, 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.