REDAPT 71354808Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556579978), received between Sep 24, 2021 and Sep 24, 2021 — classified as 1 injury.

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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A MEDICALLY INDICATED REVISION OF RIGHT HIP THA PERFORMED ON(B)(6) 2020, WHERE REDAPT SLVD MONO STEM 300MM SZ 18 SO WAS IMPLANTED, THE PATIENT WAS READMITTED DUE TO A SEROMA. AFTER 6 DAYS OF READMISSION, AN INFECTION WAS CONFIRMED WITH ELEVATED CRP AND ESR LEVELS. A RIGHT HIP DEBRIDEMENT IRRIGATION WAS PERFORMED TO TREAT THIS ADVERSE EVENT. ADDITIONAL DETAILS ABOUT PRIMARY SURGERY AND THE PATIENT'S FINAL OUTCOME 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: Seroma; Unspecified Infection

  MAUDE report 12524208 ↗

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.