REDAPT 71354709Recalls & reported problems

Summary

The FDA's MAUDE database contains 5 adverse event reports that list this exact device (DI 00885556579343), received between Dec 20, 2018 and Jun 17, 2024 — classified as 5 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (3 reports).

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 5 most recent of 5 reports, in the reporter's own words as published by the FDA.

• InjuryJun 17, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT HIP REVISION SURGERY ON (B)(6) 2020 IN WHICH SMITH & NEPHEW WERE IMPLANTED; PATIENT SUSTAINED A PATHOLOGICAL FRACTURE ON THE RIGHT FEMUR THAT REQUIRED READMISSION ON (B)(6) 2020. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Hip Fracture

  MAUDE report 19553676 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, A PATIENT UNDERWENT A THR REVISION SURGERY ON THE LEFT HIP ON (B)(6) 2017 TO TREAT AN UNSPECIFIED FEMUR MALUNION DISTAL TO THE HEAD AND NECK. DURING THIS PROCEDURE, A REDAPT SLVLS MONO STEM 240MM SZ 20 SO WAS IMPLANTED 2 WEEKS POSTOPERATIVELY, AN ADDITIONAL SURGERY WAS PERFORMED DUE TO EVACUATE AN INTERNAL HEMATOMA. ADDITIONAL DETAILS ABOUT THE IMPLANTED PROSTHESIS BEFORE THE ADDITIONAL 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: Hematoma

  MAUDE report 12524179 ↗
• InjuryNov 13, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THE PATIENT FELL AND AN X-RAY EXAMINATION BY THE PHYSICIAN DETERMINED TO PROCEED WITH REVISION SURGERY OF THE STEM.

  Patient problems: Injury

  MAUDE report 9315158 ↗
• InjuryDec 21, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION ON THE TISSUE AND HIP JOINT. DELAY OF LESS THAN 30MIN REPORTED.

  Patient problems: Injury

  MAUDE report 8189089 ↗
• InjuryDec 20, 2018Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO INFECTION ON THE TISSUE AND HIP JOINT. DELAY OF LESS THAN 30MIN REPORTED.

  Patient problems: Unspecified Infection

  MAUDE report 8184673 ↗

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.