POLARCUP 75018958Recalls & reported problems

Summary

The FDA's MAUDE database contains 4 adverse event reports that list this exact device (DI 07611996111484), received between Aug 29, 2019 and Jul 22, 2022 — classified as 4 injuries.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (1 report).

1 other recall cover devices cleared under the same FDA submission (K110135, 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 4 most recent of 4 reports, in the reporter's own words as published by the FDA.

• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A RIGHT THR PERFORMED ON (B)(6) 2018 THE PATIENT EXPERIENCED AN UNSPECIFIED INFECTION THAT WAS TREATED VIA REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE POLARCUP XLPE INSERT 53/28 NON-CEM WAS EXPLANTED ALONG WITH A FEMORAL HEAD OF A COMPETITORS BRAND. 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: Unspecified Infection

  MAUDE report 15089791 ↗
• InjurySep 27, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER THR HAD BEEN PERFORMED ON AN UNKNOWN DATE, THE PATIENT EXPERIENCED AN ASEPTIC LOOSENING. THIS ADVERSE EVENT WAS SOLVED BY REVISION SURGERY ON (B)(6) 2021. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Inadequate Osseointegration

  MAUDE report 12536741 ↗
• InjuryDec 16, 2019Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A HIP REVISION SURGERY WAS PERFORMED DUE TO INFECTION. LINER AND HEAD EXCHANGED

  Patient problems: Unspecified Infection

  MAUDE report 9474056 ↗
• InjuryAug 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  A REVISION SURGERY WAS REPORTED AS THE THR PRESENTED A CEMENT MANTLE AND THE FEMORAL HEAD WAS DISLOCATING FROM THE ACETABULAR. POLARCUP WAS NOT DISLOCATING BUT THE FEMORAL HEAD AND POLAR INSERT WAS PUNCHING OFF THE FEMORAL STEM.

  Patient problems: Injury

  MAUDE report 8946017 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K110135, 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.