NA 71302608Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 03596010194091), received between May 7, 2020 and Aug 25, 2022 — classified as 2 injuries.

The most frequently reported specific device problem is “Unintended Movement” (1 report).

1 other recall cover devices cleared under the same FDA submission (K211176, K963509); 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.

• InjuryAug 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER TOTAL HIP REPLACEMENT WAS PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THIS ADVERSE EVENT WAS TREATED BY PERFORMING A REVISION SURGERY ON (B)(6) 2022 ((B)(4)), IN WHICH THE POLY RING WAS OBSERVED TO BE DISASSEMBLED FROM THE CUP ((B)(4)). THE FEMORAL HEAD AND THE STEM WERE EXPLANTED AS WELL. IN ADDITION, WHEN THE PATIENT WAS MOVED TO BED AT THE OPERATING ROOM, HIP DISLOCATION WAS FOUND. PATIENT'S CURRENT HEALTH STATUS IS UNKNOWN.

  Patient problems: Failure of Implant; Joint Dislocation; Unspecified Infection

  MAUDE report 15294061 ↗
• InjuryMay 7, 2020Unintended Movement; Unintended Movement

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION AND PAIN. IT WAS REPORTED THAT THE OUTER CUP OF BIPOLAR WAS DISLOCATED WHEN DIACLASIS OCCURRED.

  Patient problems: Injury

  MAUDE report 10033419 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K963509. 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.