R3 71338680Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 00885556113240), received between May 26, 2019 and May 4, 2022 — classified as 3 injuries.

The most frequently reported specific device problem is “Insufficient Device Problem Information” (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 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryMay 4, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, PATIENT PRESENTED WITH A LATE-STAGE INFECTION IN THE R3 0 DEG XLPE ACET LNR 40MM X 58MM, 10 YEARS POST OP. A WASHOUT WAS PERFORMED. THE CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Unspecified Infection

  MAUDE report 14282818 ↗
• InjuryNov 23, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT UNDERWENT REVISION SURGERY DUE TO A LOOSE, INFECTED FEMORAL COMPONENT. DURING THIS PROCEDURE THE IMPLANTED LINER WAS REMOVED AND A ANTIBIOTIC SPACER WAS PUT IN PLACE. THE PATIENT THEN UNDERWENT REVISION SURGERY DUE TO A SPACER DISLOCATION (5 OR 6 WEEKS LATER DUE TO TIMEFRAME OF 2-STAGE REVISION). THE WHOLE S&N SET BEING REMOVED AND REPLACED.

  Patient problems: Impaired Healing; Joint Laxity; Osteolysis; Subluxation; Unspecified Infection

  MAUDE report 10884190 ↗
• InjuryMay 26, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT RIGHT HIP REVISION SURGERY WAS PERFORMED DUE TO PERIPROSTHETIC INFECTION.

  Patient problems: Unspecified Infection

  MAUDE report 8643153 ↗

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.