R3 71338679Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556113257), received between Feb 21, 2021 and Sep 17, 2024 — classified as 1 injury, 1 malfunction.

The most frequently reported specific device problem is “Connection Problem” (1 report).

1 other recall cover devices cleared under the same FDA submission (K093363, 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 18, 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.

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

  IT WAS REPORTED THAT THE PATIENT UNDERWENT A PRIMARY RIGHT HIP THA SURGERY ON (B)(6) 2022, DUE TO A OSTEOARTHRITIS OF RIGHT HIP. DURING THIS PROCEDURE, A COMPLETE REDAPT ACETABULAR SYSTEM WAS IMPLANTED WITH A POLARSTEM FEMORAL SYSTEM. THE PATIENT SUFFERED FROM AN INFECTION AND REQUIRED A 2 STAGE REVISION SURGERIE OF THE RIGHT PROSTHESIS. THE FIRST ON (B)(6) 2022 AND THE SECOND ONE ON (B)(6) 2022. DURING THIS REVISION, THE FEMORAL HEAD AND ACETABULAR LINER WERE EXPLANTED. THERE IS NO FURTHER INFORMATION AT THIS TIME. THE CURRENT STATE OF HEALTH OF THE PATIENT IS UNKNOWN.

  Patient problems: Medical device site infection

  MAUDE report 20239039 ↗
• MalfunctionFeb 21, 2021Connection Problem; Connection Problem

  IT WAS REPORTED THAT DURING SURGERY,0 DEGREE XLPE ACETABULAR LINER 40MM INNER DIAMETER X 56MM OD DID NOT SEAT IN TIBIAL BASE. PROCEDURE CONTINUED WITH A BACKUP DEVICE FROM SMITH AND NEPHEW, WITH A DELAY OF LESS THAN 30 MINUTES, AND WITH NO INJURY TO PATIENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11356740 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K093363, 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.