NA 71336535Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 03596010197689), received between Jun 29, 2021 and Jun 29, 2021 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K211176, K920430); 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. How this data works · Data updated Oct 13, 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.

• InjuryJun 29, 2021Break; Break

  IT WAS REPORTED THAT, DURING A HIP NECROSIS PROCEDURE, WHEN PLACING THE DEVICE, THE SCREW BROKE FROM THE UPPER PART (HEAD) AT THE TIME OF TURNING IT, SO THE SCREW GOES THROUGH THE R3 CUP. ACCORDING TO THE SALES REPRESENTATIVE IT IS NOT CERTAIN IF THE PROBLEM IS THE SCREW OR IF THE HOLE IN THE CUP IS BIGGER THAN IT SHOULD BE. NO ADDITIONAL DAMAGE WAS REPORTED. THE PROCEDURE WAS SUCCESSFULLY COMPLETED WITHOUT DELAY USING THE SAME DEVICE. THE PATIENT CONDITION WAS REPORTED AS STABLE.

  Patient problems: Necrosis

  MAUDE report 12085457 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K211176, K920430. 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.