POLARCUP 75100441Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996118322), received between May 21, 2020 and Dec 5, 2023 — classified as 1 injury, 2 malfunctions.

The most frequently reported specific device problem is “Defective Device” (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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 3 most recent of 3 reports, in the reporter's own words as published by the FDA.

• InjuryDec 5, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR SURGERY HAD BEEN PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED A GROUND-LEVEL FALL AND SUFFERED A RIGHT HIP PERIPROSTHETIC ACETABULAR FRACTURE. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021 IN WHICH A POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM, A POLARCUP XLPE INSERT 53/28 NON-CEM AND A OXINIUM FEM HD 12/14 28MM +8 WERE EXPLANTED AND THE REDAPT STEM REMAINED IN PLACE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Bone Fracture(s); Fall

  MAUDE report 18271399 ↗
• MalfunctionJul 21, 2021Defective Device; Defective Device

  IT WAS REPORTED THAT, DURING THR, A POLARCUP SHELL TI-PLASMA/HA 53 NON-CEM AND POLARCUP SHELL TI-PLASMA/HA 55 NON-CEM, WHEN OPENED, ONE OF THE TWO PROTECTIVE CAPS FOR THE INSERTION OF THE PEGS HAS NOT BEING UNSCREWED, MAKING IT IMPOSSIBLE TO USE. SURGERY WAS PERFORMED, AFTER A DELAY OF MORE THAN 30 MINUTES, WITH A COMPETITOR BACK-UP DEVICE. PATIENT WAS NOT INJURED AS CONSEQUENCE OF THIS PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12202825 ↗
• MalfunctionMay 21, 2020Mechanical Problem; Mechanical Problem

  IT WAS REPORTED THAT ONE OF THE STUDS SHUTTERS WAS UNABLE TO BE UNSCREWED. AFTER SEVERAL ATTEMPTS, THE THREAD GOT DETERIORATED. A DELAY GREATER THAN 30 MINUTES WAS RECORDED. SMITH AND NEPHEW BACKUP WAS AVAILABLE.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10078434 ↗

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.