NA 71344249Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 00885556023150), received between Jun 20, 2017 and Dec 2, 2021 — 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 (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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryDec 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR PERFORMED ON 2013, THE PATIENT EXPERIENCED RECURRENT DISLOCATIONS. THIS ADVERSE EVENT WAS SOLVED BY A REVISION SURGERY ON (B)(6) 2021, IN WHICH 40 MM OXONIUM MODULAR HEAD AND R3 20 DEG +4 XLPE ACET LNR 40 MM X 58 OD WERE EXPLANTED. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN. PREVIOUSLY, ON 2014, THE PATIENT HAD A REVISION SURGERY ALSO DUE TO DISLOCATION.

  Patient problems: Joint Dislocation

  MAUDE report 12916377 ↗
• InjuryJun 20, 2017Unintended Movement; Unintended Movement

  IT WAS REPORTED THE PATIENT PRESENTED WITH LESSER TROCHANTER FRACTURE, PERIPROSTHETIC OF THE RIGHT FEMUR AFTER THE PATIENT FELL. THE PATIENT UNDERWENT AN OPEN REDUCTION AND INTERNAL FIXATION OF THE LESSER TROCHANTER FRACTURE WITH IMPLANT EXCHANGE.

  Patient problems: Bone Fracture(s)

  MAUDE report 6654564 ↗

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.