POLARCUP 75017221Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996096460), received between Mar 12, 2020 and Jul 21, 2022 — classified as 2 injuries.

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

1 other recall cover devices cleared under the same FDA submission (K070278, 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 2 most recent of 2 reports, in the reporter's own words as published by the FDA.

• InjuryJul 21, 2022Naturally Worn; Adverse Event Without Identified Device or Use Problem; Naturally Worn; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THR REVISION SURGERY, WHERE A POLARCUP PE INSERT 49/28 NON-CEM, WAS IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2018 TO EXPLANT LINER AND HEAD, DUE TO UNEXPLAINED PAIN AND ADVERSE SOFT TISSUE REACTION TO PARTICULATE DEBRIS. CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN. THIS INFORMATION WAS PROVIDED BY THE NATIONAL JOINT REGISTRY OF THE UNITED KINGDOM, AS PART OF A RETROSPECTIVE DATA COLLECTION OF PATIENTS WHO UNDERWENT EITHER A REVISION OR RE-REVISION SURGERY WHERE A POLARCUP SHELL WAS PART OF THE HIP CONSTRUCT. AS SUCH, NO FURTHER INFORMATION WILL BE AVAILABLE.

  Patient problems: Foreign Body Reaction; Hypersensitivity/Allergic reaction; Pain

  MAUDE report 15080192 ↗
• InjuryMar 12, 2020Unstable; Unstable

  IT WAS REPORTED THAT A LEFT HIP REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. SURGEON FOUND IN SITU THE MOBILE ACETABULAR INSERT OUTSIDE OF THE PROSTHETIC CUP. THE DISLOCATION WAS NOT REDUCIBLE, THUS WALKING WAS IMPOSSIBLE AND REVISION SURGERY WAS IMPOSSIBLE TOO. CHANGE OF CUP AND INSERT. UNKNOWN IF THERE WAS A DELAY DURING THE PROCEDURE.

  Patient problems: Injury

  MAUDE report 9824238 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K070278, 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.