POLARCUP 75017222Recalls & reported problems

Summary

The FDA's MAUDE database contains 2 adverse event reports that list this exact device (DI 07611996096477), received between Jul 21, 2022 and Jul 22, 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 22, 2022Naturally Worn; Naturally Worn

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2008, THE PATIENT EXPERIENCED PAIN, LOOSENING OF THE ACETABULAR CUP AND WEAR OF THE LINER. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR CUP, THE LINER AND HEAD WERE EXPLANTED. THE PATIENT'S HEALTH STATUS IS NOT KNOWN. 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: Failure of Implant; Inadequate Osseointegration; Pain

  MAUDE report 15086254 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A RIGHT THA HAD BEEN PERFORMED ON (B)(6) 2010, THE PATIENT EXPERIENCED A DISSOCIATION OF THE ACETABULAR LINER. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2019 TO TREAT THIS ADVERSE EVENT. DURING THIS PROCEDURE, THE ACETABULAR CUP, THE LINER, HEAD AND STEM WERE EXPLANTED. THE PATIENT'S HEALTH STATUS 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: Failure of Implant; Inadequate Osseointegration; Osteolysis

  MAUDE report 15079635 ↗

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.