POLARCUP 75018955Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611996111453), received between Jan 9, 2020 and Jul 22, 2022 — classified as 7 injuries, 1 malfunction.

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. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 8 most recent of 8 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 REVISION SURGERY PERFORMED WHERE A POLARCUP SHELL 47 CEMENTED AND A POLARCUP XLPE INSERT 47/28 NON-CEM WERE IMPLANTED, PATIENT EXPERIENCED AN UNSPECIFIED INFECTION. THIS COMPLICATION WAS ADDRESSED BY CONDUCTING A REVISION SURGERY ON (B)(6) 2014. ALL PROTHESIS COMPONENTS WERE EXPLANTED AND REPLACED WITH COMPETITORS' IMPLANTS.. THE PATIENT'S OUTCOME 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: Unspecified Infection

  MAUDE report 15089858 ↗
• 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, WHERE A POLARCUP XLPE INSERT 47/28 NON-CEM AND A POLARCUP SHELL 47 CEMENTED WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2021 TO EXPLANT CUP, LINER AND HEAD, DUE TO DISSOCIATION OF THE LINER. 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 15080909 ↗
• InjuryJul 21, 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) 2019, THE PATIENT EXPERIENCED AN INFECTION. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2019, WHERE THE STEM, CUP, FEMORAL HEAD AND LINER WERE EXPLANTED AND REPLACED. FEMORAL HEAD AND STEM WERE FROM A COMPETITOR DEVICE. 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: Unspecified Infection

  MAUDE report 15080847 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT AFTER A LEFT THR PERFORMED ON (B)(6) 2016, THE PATIENT PRESENTED INFECTION. THIS ADVERSE EVENT WAS TREATED VIA REVISION SURGERY ON (B)(6) 2017 AND WERE POLARCUP XLPE INSERT 47/28 NON-CEM WAS EXPLANTED. 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. ALL AVAILABLE INFORMATION HAS BEEN DISCLOSED. IF ADDITIONAL INFORMATION SHOULD BECOME AVAILABLE, A SUPPLEMENTAL REPORT WILL BE SUBMITTED ACCORDINGLY.

  Patient problems: Post Operative Wound Infection; Unspecified Infection

  MAUDE report 15080777 ↗
• 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 XLPE INSERT 47/28 NON-CEM. TI/HA 4 WERE IMPLANTED, THE PATIENT UNDERWENT A REVISION SURGERY ON (B)(6) 2019 TO EXPLANT CUP, LINER, HEAD AND STEM, DUE TO UNSPECIFIED REASONS. 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: Insufficient Information

  MAUDE report 15079754 ↗
• InjuryJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA WAS PERFORMED ON (B)(6) 2018, THE PATIENT EXPERIENCED DISLOCATION AND/OR SUBLUXATION OF THE JOINT PROSTHESIS. THIS ADVERSE EVENT WAS TREATED BY A REVISION SURGERY ON (B)(6) 2018. DURING THIS PROCEDURE, THE POLARCUP XLPE INSERT 47/28 NON-CEM WAS EXPLANTED AND EXCHANGED WITH COMPETITORS' DEVICES. THE PATIENT'S OUTCOME 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; Subluxation

  MAUDE report 15079581 ↗
• InjuryFeb 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER PRIMARY THR, A REVISION SURGERY WAS PERFORMED DUE TO A DISLOCATION. THE POLARCUP XLPE INSERT 47/28 NON-CEM WAS EXPLANTED. THE OUTCOME OF THE PATIENT IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11305594 ↗
• MalfunctionJan 9, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT LINER DISASSOCIATED FROM HEAD WHEN THE LIP OF THE CUP INTERPOSED ITSELF BETWEEN THE LINER AND HEAD. BOTH DEVICES WERE REASSEMBLED WITH NO SUCCESS. SURGEON DECIDED TO USE ENTIRE NEW IMPLANTS SINCE NO BACKUP WAS AVAILABLE. DELAY NO GREATER THAN 30 MINUTES WAS REPORTED.

  Patient problems: No Information

  MAUDE report 9568380 ↗

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.