POLARCUP 75018957Recalls & reported problems

Summary

The FDA's MAUDE database contains 8 adverse event reports that list this exact device (DI 07611996111477), received between Jan 4, 2018 and Mar 13, 2024 — classified as 7 injuries, 1 malfunction.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (2 reports).

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.

• InjuryMar 13, 2024Device Dislodged or Dislocated; Unintended Movement; Insufficient Device Problem Information; Device Dislodged or Dislocated; Unintended Movement; Insufficient Device Problem Information

  IT WAS REPORTED THAT, AFTER A THR SURGERY PERFORMED ON AN UNSPECIFIED DATE, A REVISION SURGERY WAS PERFORMED ON (B)(6) 2024 IN ORDER TO REPLACE THE POLY LINER DUE TO DISLOCATION. THE CURRENT HEALTH STATUS OF THE PATIENT IS UNKNOWN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18894323 ↗
• 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: Unspecified Infection

  MAUDE report 15089528 ↗
• 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) 2013, THE PATIENT PRESENTED UNEXPLAINED PAIN THAT WAS ADDRESSED VIA REVISION SURGERY ON (B)(6) 2014. THE POLARCUP XLPE INSERT 51/28 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: Pain

  MAUDE report 15080792 ↗
• 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: Subluxation

  MAUDE report 15080435 ↗
• InjuryNov 10, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THR HAD BEEN PERFORMED ON (B)(6) 2020, THE PATIENT EXPERIENCED A DISLOCATION AFTER A FALL. A REVISION SURGERY WAS PERFORMED ON (B)(6) 2020 TO EXCHANGE THE POLARCUP INSERT. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 10815691 ↗
• InjuryOct 8, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO RECURRENT DISLOCATION. HEAD AND LINER WERE EXPLANTED AND CHANGED FOR PATS OF THE SAME SIZE. THE OTHER IMPLANTS REMAINED IN SITU. NO INFORMATION ABOUT THE PATIENT STATUS WAS INITIALLY PROVIDED.

  Patient problems: Injury

  MAUDE report 10652311 ↗
• MalfunctionAug 15, 2020Off-Label Use; Improper or Incorrect Procedure or Method; Off-Label Use; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT DURING PROCEDURE, AFTER THE SURGEON FIXED THE SHELL TO THE ACETABULUM, THE NURSE FIGURED OUT THAT THE INSERT IS RE-STERILIZED MANUALLY BEFORE NOT SUPPLIED WITH THE COMPANY¿S SEAL ON THE PRODUCT AS USUAL. THR FINISHED WITH SAME DEVICE, NO SUBSTANTIAL DELAYS WERE REPORTED.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10411814 ↗
• InjuryJan 4, 2018Loose or Intermittent Connection; Loose or Intermittent Connection

  IT WAS REPORTED THAT THE HEAD OF THE PROTHESIS CAME OUT OF THE POLYETHYLENE AND LED TO A DISLOCATION OF THE PROTHESIS. A REVISION SURGERY HAD TO BE PERFORMED WITH A NEW HEAD AND INSERT BEING FITTED.

  Patient problems: Discomfort

  MAUDE report 7166325 ↗

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.