R3 71338683Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 00885556113219), received between Jan 31, 2020 and Jan 31, 2020 — classified as 1 injury.

The most frequently reported specific device problem is “Unintended Movement” (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 1 most recent of 1 reports, in the reporter's own words as published by the FDA.

• InjuryJan 31, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT THE PATIENT UNDERWENT TWO CLOSED REDUCTIONS DUE TO RECURRENT DISLOCATIONS. THE FIRST CLOSED REDUCTION WAS PERFORMED ON (B)(6) 2018 AND THE SECOND ONE ON (B)(6) 2018.

  Patient problems: Injury; Joint Dislocation

  MAUDE report 9653097 ↗

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.