R3 71338695Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556113110), received between Nov 15, 2021 and Nov 15, 2021 — classified as 1 injury.

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

• InjuryNov 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE CUP HAD LOOSENED AND SPUN, CAUSING A LEG LENGTH SHORTENING. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY PERFORMED ON (B)(6)2021, IN WHICH THE ORIGINAL CUP WAS EVALUATED AND DETERMINED TO BE WELL FIXED AFTER SCREW REMOVAL. HOWEVER, THE R3 0 DEG +4 XLPE ACET LNR 40 MM ID X 56 OD AND 40 MM OXONIUM MODULAR HEAD WERE REPLACED, AND THE PLACEMENT OF THE NEW LINER AND HEAD ACCOUNTED FOR THE COMPLAINT OF LEG LENGTH DISCREPANCY, WHICH WAS EVALUATED THROUGH FULL ROM AND STABLE.

  Patient problems: Failure of Implant

  MAUDE report 12815568 ↗

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.