POLARCUP 75100437Recalls & reported problems

Summary

The FDA's MAUDE database contains 1 adverse event report that list this exact device (DI 07611996118285), received between Jun 24, 2021 and Jun 24, 2021 — classified as 1 injury.

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

1 other recall cover devices cleared under the same FDA submission (K122244, 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. 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 24, 2021Fitting Problem; Mechanical Jam; Positioning Problem; Physical Resistance/Sticking; Fitting Problem; Mechanical Jam; Positioning Problem; Physical Resistance/Sticking

  IT WAS REPORTED THAT A REVISION OF A 40 MM PINNACLE CUP AND EXETER STEM WAS PERFORMED DUE TO INSTABILITY. A 45 MM POLAR CUP WITH SCREWS AND FLANGES WAS CHOSEN. AFTER TRIALING, IT WAS DECIDED PEGS WERE NECESSARY. FIRST PEG HOLE WAS REMOVED UNEVENTFULLY BUT THE SECOND BECAME STUCK AFTER INITIALLY TURNING. ATTEMPTS TO KEEP REMOVING ROUNDED THE HEX IN COVER. EVENTUALLY, HOLE COVER WAS REMOVED USING MIDAS REX CAUSING A DELAY OF 30 MINUTES OR MORE. CUP WAS IMPLANTED, PEG HOLES DRILLED AND PEGS IMPACTED. UNFORTUNATELY THE PEGS DIDN¿T IMPACT ALL THE WAY IN AND WERE LEFT PROUD. IT WAS DECIDED THIS WAS AN UNACCEPTABLE RISK TO THE POLY AND CUP WAS REMOVED. SURGERY WAS FINISHED USING A COMPETITOR'S DEVICE. NO PATIENT HARM REPORTED.

  Patient problems: Failure of Implant

  MAUDE report 12058774 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K122244, 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.