POLARCUP 75018942Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 07611996111323), received between Dec 27, 2017 and Apr 22, 2024 — classified as 9 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Device Dislodged or Dislocated” (7 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. 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 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• InjuryApr 22, 2024Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT, AFTER A REVISION SURGERY ON THE PATIENT'S LEFT HIP ON (B)(6) 2018, DUE TO AN ACETABULUM FRACTURE; PATIENT EXPERIENCE A DISLOCATION THAT REQUIRED RE-REVISION ON (B)(6) 2018. CURRENT PATIENT'S HEALTH STATUS IS UNKNOWN. NO OTHER COMPLICATIONS WERE REPORTED.

  Patient problems: Joint Laxity

  MAUDE report 19160431 ↗
• MalfunctionApr 10, 2024Positioning Failure; Positioning Failure

  IT WAS REPORTED THAT DURING THR SURGERY ONE (1) POLARCUP XLPE INSERT 43/22 NON-CEM WAS PLACED IN THE PRESS WITH THE 22 HEAD. IT SEEMED TO HAVE CREATED A VACUUM, AS THE HEAD MOVED INSIDE THE INSERT AND APPEARED TO BE FINE. HOWEVER, WHEN PLACING THE INSERT ON THE PATIENT AND REDUCING IT, THE INSERT CAME LOOSE FROM THE HEAD. THEY HAD TO REMOVE THE HEAD FROM THE STEM. THE PROCESS OF INSERTING THE HEAD INTO THE INSERT WAS REPEATED, AND WHEN REDUCING IT AGAIN, THE EXACT SAME ISSUE OCCURRED. THE TREATMENT WAS RESUMED AFTER A SIGNIFICANT DELAY, USING A S+N BACK-UP DEVICE, WHICH WAS IMPLANTED CORRECTLY. NO INJURIES WERE REPORTED AS A CONSEQUENCE OF THIS ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19084373 ↗
• InjuryApr 19, 2022Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem; Device Dislodged or Dislocated; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A THA HAD BEEN PERFORMED ON (B)(6) 2022, THE PATIENT EXPERIENCED A DISLOCATION AFTER BECOMING INTOXICATED AND FALLING. IT WAS TRIED TO SOLVE BY A CLOSE REDUCTION TO PLACE HEAD/INSERT CONSTRUCT BACK INTO SHELL. DURING REDUCTION THE HEAD/INSERT WAS DIFFICULT TO REDUCE AND ULTIMATELY THE 22MM HEAD DISSOCIATED FROM THE XLPE INSERT. A REVISION SURGERY WILL BE PERFORMED ON AN UNSPECIFIED DATE. CURRENT HEALTH STATUS OF PATIENT IS UNKNOWN.

  Patient problems: Fall; Joint Dislocation

  MAUDE report 14142968 ↗
• InjuryMay 12, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT, AFTER A FIRST REVISION SURGERY HAD BEEN PERFORMED ON (B)(6) 2013, THE PATIENT HAD ANOTHER DISLOCATION (IT WAS STATED THAT THE PATIENT WAS NON-COMPLIANT). A SECOND REVISION SURGERY WAS PERFORMED ON (B)(6) 2021 TO REPLACE THE 43MM XLPE INSERT 43MM/22MM. THE PATIENT OUTCOME IS UNKNOWN.

  Patient problems: Joint Dislocation

  MAUDE report 11812815 ↗
• InjuryDec 23, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THE PATIENT DISLOCATED. AND A CLOSED REDUCTION WAS PERFORMED AND FAILED. REVISION SURGERY WAS PERFORMED AND IMPLANTS OF THE SAME SIZE WERE IMPLANTED. NO PATIENT INFORMATION IS AVAILABLE.

  Patient problems: Joint Dislocation

  MAUDE report 11069735 ↗
• MalfunctionOct 2, 2020Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT REVISION SURGERY WAS PERFORMED DUE TO DISLOCATION. THE POLARCUP XLPE INSERT 43/22 NON-CEM WAS REMOVED AND REPLACED WITH ANOTHER INSERT OF THE SAME SIZE.

  Patient problems: Injury

  MAUDE report 10621588 ↗
• InjuryMar 24, 2020Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED BECAUSE THE INSERT WAS SMALLER THAN IT WAS LABELED CAUSING IT TO FAIL. APPARENTLY THE DEVICE WAS INCORRECTLY MANUFACTURED.

  Patient problems: Injury

  MAUDE report 9874362 ↗
• InjuryOct 29, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT A REVISION SURGERY WAS PERFORMED DUE TO CONSISTENT DISLOCATION. PATIENT WAS NON COMPLIANT.

  Patient problems: Injury

  MAUDE report 9253399 ↗
• InjuryAug 22, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

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

  Patient problems: Unspecified Infection

  MAUDE report 8923712 ↗
• InjuryMar 26, 2019Device Dislodged or Dislocated; Device Dislodged or Dislocated

  IT WAS REPORTED THAT THIS IS THE THIRD REVISION DUE TO HIP DISLOCATION.

  Patient problems: Injury

  MAUDE report 8453615 ↗
• InjuryDec 27, 2017Insufficient Device Problem Information; Insufficient Device Problem Information

  PATIENT HAD INFECTION DUE TO CYSTITIS OVER THE HIP AND DEBRIDEMENT WAS DONE TODAY. CHANGING OF THE LINER IS THE NEXT STEP OF ACTION.

  Patient problems: Unspecified Infection

  MAUDE report 7147832 ↗

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.