REDAPT 71354825Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556580127), received between Sep 23, 2021 and Feb 11, 2022 — 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.

• InjuryFeb 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A LARGE ONGOING WOUND INFECTION THAT EXTENDED INTO THE PATIENT'S HIP JOINT. PREVIOUS WASHOUTS HAD BEEN PERFORMED, BUT THE INFECTION WAS UNABLE TO BE CLEARED. THEREFORE, REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2022 IN ORDER TO SOLVE THIS ADVERSE EVENT. THE REDAPT SLVD MONO STEM 240MM SZ 18 HO WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 13515156 ↗
• InjurySep 23, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER MEDICALLY INDICATED REVISION OF RIGHT TOTAL HIP, PERFORMED ON (B)(6) 2018, WHERE REDAPT SLVD MONO STEM 240MM SZ 18 HO WAS IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY DUE TO INSTABILITY/INFECTION 3 WEEKS POST OP. IT WAS NOT REPORTED WHICH DEVICES WERE EXPLANTED. 6 WEEKS POST OP, THE PATIENT PRESENTED AMBULATION WITH AN ANTALGIC GAIT ON THE RIGHT SIDE AND WITH A ROLLING WALKER ASSIST. THE OUTCOME OF THE PATIENT IS UNKNOWN. ADDITIONAL DETAILS ABOUT PRIMARY SURGERY ARE UNKNOWN. PATIENT OUTCOME IS 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: Ambulation or Postural Difficulties; Joint Laxity; Unspecified Infection

  MAUDE report 12523752 ↗

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.