POLARCUP 75100455Recalls & reported problems

Summary

The FDA's MAUDE database contains 3 adverse event reports that list this exact device (DI 07611996118469), received between Jul 21, 2022 and Dec 4, 2024 — classified as 3 injuries.

The most frequently reported specific device problem is “Migration” (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 18, 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 4, 2024Migration; Migration

  IT WAS REPORTED THAT AFTER UNDERGOING A THA IN HER RIGHT HIP JOINT IN (B)(6) 2023, PATIENT EXPERIENCED FAILED TOTAL HIP ARTHROPLASTY. PATIENT DEVELOPED INCREASING HIP PAIN, X RAYS WERE OBTAINED WHICH SHOWED THE ACETABULAR COMPONENT HAD FAILED AND MIGRATED. THIS ADVERSE EVENT WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2024, DURING WHICH, DUE TO THE PELVIC DISCONTINUITY, SURGEON IMPLANTED A CUSTOM TRI FLANGE CUP ALONG WITH CONVERSION TO TOTAL HIP ARTHROPLASTY. DURING PROCEDURE, THERE WAS SEROUS FLUID AROUND THE HIP, ALTHOUGH, THERE WAS NOT ANY SIGNS OF PUS OR OBVIOUS INFECTION. IN ADDITION, THERE WAS ABUNDANT DENSE SCAR TISSUE THAT TOOK SIGNIFICANT TIME TO DISSECT OUT AND CLEAR UP THE BORDERS AROUND THE ACETABULUM. THE INCISION WAS DRESSED WITH A STERILE DRESSING AND THE PATIENT WAS AWAKENED AND TAKEN TO THE PACU IN STABLE CONDITION. THE PATIENT TOLERATED THE PROCEDURE WELL, THERE WERE NO COMPLICATIONS, AND HEMOVAC DRAIN WAS PLACED.

  Patient problems: Failure of Implant; Pain

  MAUDE report 20844914 ↗
• InjuryJul 22, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA SURGERY WAS PERFORMED ON (B)(6) 2017, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2020, IN WHICH THE STEM, CUP, HEAD AND LINER WERE EXPLANTED AND REPLACED WITH A NEW THR SYSTEM. THE CURRENT HEALTH STATUS OF 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: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 15089622 ↗
• 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 THR REVISION SURGERY WAS PERFORMED, IN WHICH A POLARCUP SHELL 51 CEMENTED AND A POLARCUP XLPE INSERT 51/28 NON-CEM WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2016 TO EXPLANT CUP, LINER, HEAD AND STEM, DUE TO DISLOCATION/SUBLUXATION. 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: Joint Dislocation

  MAUDE report 15080437 ↗

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.