REDAPT 71354865Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556580486), received between Sep 24, 2021 and Apr 19, 2024 — classified as 3 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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryApr 19, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, SEVEN (7) MONTHS AFTER A LEFT THA RE-REVISION WITH RESECTION PERFORMED ON AN UNKNOWN DATE DUE TO INFECTION, THE PATIENT REQUIRED AN ADDITIONAL REVISION DUE TO RECURRING INFECTION. NO FURTHER INFORMATION IS AVAILABLE.

  Patient problems: Drug Resistant Bacterial Infection; Unspecified Infection

  MAUDE report 19149127 ↗
• 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 THA REVISION OF AN UNSPECIFIED HIP HAD BEEN PERFORMED ON (B)(6) 2020, WHERE REDAPT SLVD MONO STEM 300MM SZ 22 HO WAS IMPLANTED, A POSSIBLE DVT OR INFECTION WAS DETECTED IN THE PATIENT. FURTHER INFORMATION REGARDING THE CLARIFICATION OF THIS DIAGNOSIS OR TREATMENT WAS NOT AVAILABLE. THE PATIENT ALSO EXPERIENCED A MILD POSTOPERATIVE DISCOMFORT 9 MONTHS AFTER THE REVISION SURGERY WAS PERFORMED. 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: Discomfort; Insufficient Information

  MAUDE report 12529665 ↗
• InjurySep 24, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 8 MONTHS AFTER MEDICALLY INDICATED REVISION OF LEFT TOTAL HIP PERFORMED ON (B)(6) 2018 WHERE REDAPT SLVD MONO STEM 300MM SZ 22 HO WAS IMPLANTED, THE PATIENT UNDERWENT ANOTHER REVISION SURGERY WITH HARDWARE REMOVAL DUE TO RECALCITRANT BURSITIS WITH PROMINENT TROCHANTERIC CABLE PLATE. IT IS UNKNOWN WHAT DEVICES WERE EXPLANTED FROM THE PATIENT. 2 YEARS AFTER THE SURGERY, THE PATIENT STILL REPORTED SOME PAIN IN THE LEFT LEG WITH TROCHANTERIC NONUNION. 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: Inadequate Osseointegration; Inflammation

  MAUDE report 12529593 ↗

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.