R3 71330766Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556020296), received between Feb 10, 2022 and Feb 10, 2022 — classified as 1 injury.

1 other recall cover devices cleared under the same FDA submission (K092386, 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.

• InjuryFeb 10, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2021, THE PATIENT EXPERIENCED A LARGE ONGOING WOUND INFECTION THAT EXTENDED INTO THE PATIENT'S HIP JOINT. PREVIOUS WASHOUTS HAD BEEN PERFORMED, BUT THE INFECTION WAS UNABLE TO BE CLEARED. THEREFORE, REVISION SURGERY WAS CARRIED OUT ON (B)(6) 2022 IN ORDER TO SOLVE THIS ADVERSE EVENT. THE R3 0DEG XLPE ACET LNR 36 X 66/70 WAS EXPLANTED. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: Failure of Implant; Unspecified Infection

  MAUDE report 13510768 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K092386, 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.