REDAPT 71354738Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556579596), received between Sep 14, 2021 and Sep 14, 2021 — classified as 1 injury.

The most frequently reported specific device problem is “Loosening of Implant Not Related to Bone-Ingrowth” (1 report).

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. 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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjurySep 14, 2021Loosening of Implant Not Related to Bone-Ingrowth; Loosening of Implant Not Related to Bone-Ingrowth

  IT WAS REPORTED THAT, AFTER A REVISION THR HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A DISLOCATION AND IT WAS DETERMINED THAT THE STEM WAS LOOSE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 12471544 ↗

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.