REDAPT 71354822Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556580097), received between Sep 24, 2021 and Dec 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.

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

  IT WAS REPORTED THAT, AFTER A REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED PAIN AND SHORTENING. A REVISION SURGERY WAS BOOKED ON (B)(6) 2022 TO ADDRESS THIS EVENT. THE ACETABULAR COMPONENTS, FROM ZIMMER, WERE RETAINED, WHILE THE FEMORAL COMPONENTS (REDAPT STEM AND SLEEVE AND AN OXINIUM HEAD) WERE REMOVED. A SPECTRON REVISION STEM WAS INSERTED IN EXCHANGE. THE PATIENT IS RECOVERING.

  Patient problems: Pain

  MAUDE report 15956511 ↗
• InjurySep 24, 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 15 HO WAS IMPLANTED, PATIENT EXPERIENCED DRAINING SINUS APPRECIATED ABOUT THE MEDIAL ASPECT OF THE INCISION WITH SIGNIFICANT AMOUNT OF PURULENCE DRAINAGE. PATIENT DENIED ANY PAIN. IT IS UNKNOWN IF OR HOW THE ADVERSE EVENT WAS TREATED. 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: Purulent Discharge; Unspecified Infection

  MAUDE report 12524242 ↗

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.