REDAPT 71354041Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556023969), received between Sep 27, 2021 and Sep 27, 2021 — classified as 1 injury.

2 other recalls cover devices cleared under the same FDA submission (K081124); 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON (B)(6) 2018, THE PATIENT PRESENTED TO HOSPITAL WITH A SIGNIFICANT INFECTION AND AN ABSCESS OF HIS RIGHT HIP EXTENDING DISTALLY TO APPROXIMATELY 10CM PROXIMAL TO THE KNEE. THIS ADVERSE SITUATION WAS TREATED WITH A REVISION SURGERY PERFORMED ON (B)(6) 2021, WHERE THE REDAPT 300MM SLEEVED REVISION STEM SIZE 13 HIGH OFFSET, THE REDAPT MODULAR SLEEVE MEDIUM SIZE 12-13 STIKTITE WITH HYDROXYAPATITE AND THE BIOLOX DELTA HEAD 36 MM 12/14 LONG / +8 WERE REMOVED. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Abscess; Unspecified Infection

  MAUDE report 12537696 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K081124. One submission often covers many models, so check the product and lot details in each record.

• Z-0945-2017 · Nov 15, 2016 · Terminated
  Modular SMF(TM) The Modular SMF(TM) and Modular REDAPT(TM) Hip Systems are indicated for individuals undergoing primary and revision surgery where other treatments or devices have
• Z-2427-2012 · Aug 22, 2012 · Terminated
  12/14 TAPER HIGH OFFSET NECK USE WITH SMITH & NEPHEW STEMS AND 12/14 FEMORAL COMPONENTS ONLY CO-CR, REF 71352112, Smith & Nephew, Inc. Memphis, TN 38116 USA. USE WITH SMITH & NEPH